CATALOG SOLUTII ANTEPICIOR, INTEGRA (USA) in Romania prin ENLIFE SOLUTIONS

IntegraÂŽ Forefoot Product Catalogue

Table of content

Forefoot set II ����������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 4 - complete set - sterile and non sterile version - screw module - sterile and non sterile version - staple module - sterile and non sterile version Osteoguides ������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ 24 Forefoot Removal instruments ����������������������������������������������������������������������������������������������������������������������������������������������������� 25 Ti6® Screw system �������������������������������������������������������������������������������������������������������������������������������������������������������������������������� 26 K-FIX® - K-wire end protector ������������������������������������������������������������������������������������������������������������������������������������������������������ 32 IPP-ON® anatomic proximal interphalangeal joint fusion implant ������������������������������������������������������������������������������������������33 K2™ hemi toe implant system ����������������������������������������������������������������������������������������������������������������������������������������������������� 34 Movement™ great toe system ����������������������������������������������������������������������������������������������������������������������������������������������������� 36 HALLU®-LOCK M.T.P. arthrodesis system ������������������������������������������������������������������������������������������������������������������������������������ 38 HALLU®-FIX M.T.P. arthrodesis system ����������������������������������������������������������������������������������������������������������������������������������������40 HALLU®-REAM metatarsal reamers; phalangeal reamers ��������������������������������������������������������������������������������������������������������� 42 HALLU® Removal instruments ����������������������������������������������������������������������������������������������������������������������������������������������������� 43 DPR System Minimal Invasive Foot Surgery ������������������������������������������������������������������������������������������������������������������������������� 44 Post operative shoes ���������������������������������������������������������������������������������������������������������������������������������������������������������������������� 45

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

3

Forefoot

Complete Forefoot Set II A new modular and scalable forefoot instruments set: • • • • •

Bold® 2.5 – 3.0 – 3.7 Compression screws.

QWIX® 3.0 Fixation screw.

Spin® 2.0 – 2.7 Snapp-Off screws.

Solustaple® Standard staple.

Uni-clip® Compression Staple.

Compression Screws

Fixation Screws

Bold®

QWIX®

Standard Staple

Compression Staple

Snap-Off

Solustaple®

Uni-Clip®

Spin®

Screw instrumentation module

Staple instrumentation module

Implant rack module

Frame

4

229996

2 floors caddy

229990

3 floors caddy

229970

Forefoot II lid

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Generic module

Forefoot

- Non sterile Implants - Staple instrumentation - Screw instrumentation

forefoot

- Staple instrumentation - Screw instrumentation

- Non sterile Implants - Generic module - Screw instrumentation

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

5

Forefoot

Complete Forefoot Set II - Sterile version

Compression Screws

Fixation Screws

Standard Staple

Compression Staple

Snap-Off

Bold®

QWIX®

Solustaple®

Uni-Clip®

Spin®

229993 INSTRUMENT TRAY Complete set - sterile version Including: Reference

Description

229996

2 floors caddy

229970

Forefoot II lid

229961

Tray - screw ancillaries

229992

Mat - screws ancillaries

229962

Tray - staples ancillaries

: Available in spare part for replacement

6

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Instrumentation - screws module

Instrumentation - staples module

Reference

Description

Reference

Description

119105

BOLD® clamp

229201

UNI-CLIP® drilling guide

229002

Cannulated hexagonal screwdriver 2mm

229202

Impactor

229005

Cannulated hexagonal screwdriver AO tip 2mm

119311

UNI-CLIP® spreading forceps

229003

Cannulated screwdriver T7

229101

SOLUSTAPLE® drilling guide

229004

AO cannulated screwdriver T7

229102

SOLUSTAPLE® 26° and 90° impactor

229301

SPIN® screwdriver

997301

Depth gauge

997311

Straight AO handle

119307

UNI-CLIP® Depth Gauge

229101

SOLUSTAPLE® drilling guide

Drills & K-wires

997301

Depth gauge

Reference

Description

115100S

K-wire dia. 1.0mm L.100mm - 2 sharps

Drills & K-wires Reference

Description

115070S

K-wire dia. 1.0mm L.70mm - 1 sharp

119027S

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

119006S

Drill dia. 2.2mm L.41mm

119025S

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

119004S

Cannulated drill dia.2,2mm L 90mm

119023S

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

159027S

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

159025S

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

159023S

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

119227S

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.12mm

119225S

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.22mm

119223S

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.32mm

159227S

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.12mm

159225S

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.22mm

159223S

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.32mm

115070S

K-wire dia. 1.0mm L.70mm - 1 sharp

115100S

K-wire dia. 1.0mm L.100mm - 2 sharps

229227S

BOLD® 2.5 « 2 in 1» cannulated L.12mm

229237S

BOLD® 2.5 « 2 in 1» cannulated drill L.22mm

229027S

BOLD® 2.5 « 2 in 1» cannulated drill L.12mm AO

229037S

BOLD® 2.5 « 2 in 1» cannulated drill L.22mm AO

229028S

BOLD® 2.5 « 2 in 1» non cannulated drill L.12mm AO

229038S

BOLD® 2.5 « 2 in 1» non cannulated drill L.22mm AO

229228S

BOLD® 2.5 « 2 in 1» non cannulated drill L.12mm

229238S

BOLD® 2.5 « 2 in 1» non cannulated drill L.22mm

115008S

K-wire dia. 0.8mm L.70mm - 1 sharp - 1 blunt

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

forefoot

Forefoot

7

Forefoot

Implant Bold® Compression Screw Dia. 2.5mm / 3.0mm / 3.7mm

8

Reference

Description

111320S

QWIX® screw dia. 3mm L.20mm

200010S

BOLD® 2.5mm Compression screw L.10mm

111322S

QWIX® screw dia. 3mmL.22mm

200012S

BOLD® 2.5mm Compression screw L.12mm

111324S

QWIX® screw dia. 3mm L.24mm

200014S

BOLD® 2.5mm Compression screw L.14mm

111326S

QWIX® screw dia. 3mm L.26mm

200016S

BOLD® 2.5mm Compression screw L.16mm

111328S

QWIX® screw dia. 3mm L.28mm

200018S

BOLD® 2.5mm Compression screw L.18mm

111330S

QWIX® screw dia. 3mm L.30mm

200020S

BOLD® 2.5mm Compression screw L.20mm

111332S

QWIX® screw dia. 3mm L.32mm

200022S

BOLD® 2.5mm Compression screw L.22mm

111334S

QWIX® screw dia. 3mm L.34mm

200024S

BOLD® 2.5mm Compression screw L.24mm

SPIN® Snap-Off Screw, Dia. 2.0mm / 2.7mm

200026S

BOLD® 2.5mm Compression screw L.26mm

Reference

Description

200028S

BOLD® 2.5mm Compression screw L.28mm

112011S

SPIN® screw dia. 2mm L.11mm

200030S

BOLD® 2.5mm Compression screw L.30mm

112012S

SPIN® screw dia. 2mm L.12mm

111010S

BOLD® 3mm compression screw L.10mm

112013S

SPIN® screw dia. 2mm L.13mm

111012S

BOLD® 3mm compression screw L.12mm

112014S

SPIN® screw dia. 2mm L.14mm

111014S

BOLD® 3mm compression screw L.14mm

112111S

SPIN® screw dia. 2.7mm L.11mm

111016S

BOLD® 3mm compression screw L.16mm

112112S

SPIN® screw dia. 2.7mm L.12mm

111018S

BOLD® 3mm compression screw L.18mm

112113S

SPIN® screw dia. 2.7mm L.13mm

111020S

BOLD® 3mm compression screw L.20mm

112114S

SPIN® screw dia. 2.7mm L.14mm

111022S

BOLD® 3mm compression screw L.22mm

UNI-CLIP® Notched Staples

111024S

BOLD® 3mm compression screw L.24mm

Reference

Description

111026S

BOLD® 3mm compression screw L.26mm

213113S

Notched UNI-CLIP® interaxis 11 - L.13mm

111028S

BOLD® 3mm compression screw L.28mm

213114S

Notched UNI-CLIP® interaxis 11 - L.14mm

111030S

BOLD® 3mm compression screw L.30mm

213115S

Notched UNI-CLIP® interaxis 11 - L.15mm

111032S

BOLD® 3mm compression screw L.32mm

213116S

Notched UNI-CLIP® interaxis 11 - L.16mm

111034S

BOLD® 3mm compression screw L.34mm

213117S

Notched UNI-CLIP® interaxis 11 - L.17mm

131014S

BOLD® 3.7mm Compression screw L.14mm

213213S

Notched UNI-CLIP® interaxis 12 - L.13mm

131016S

BOLD® 3.7mm Compression screw L.16mm

213214S

Notched UNI-CLIP® interaxis 12 - L.14mm

131018S

BOLD® 3.7mm Compression screw L.18mm

213215S

Notched UNI-CLIP® interaxis 12 - L.15mm

131020S

BOLD® 3.7mm Compression screw L.20mm

213216S

Notched UNI-CLIP® interaxis 12 - L.16mm

131022S

BOLD® 3.7mm Compression screw L.22mm

213217S

Notched UNI-CLIP® interaxis 12 - L.17mm

131024S

BOLD® 3.7mm Compression screw L.24mm

213313S

Notched UNI-CLIP® interaxis 13 - L.13mm

131026S

BOLD® 3.7mm Compression screw L.26mm

213314S

Notched UNI-CLIP® interaxis 13 - L.14mm

131028S

BOLD® 3.7mm Compression screw L.28mm

213315S

Notched UNI-CLIP® interaxis 13 - L.15mm

131030S

BOLD® 3.7mm Compression screw L.30mm

213316S

Notched UNI-CLIP® interaxis 13 - L.16mm

131032S

BOLD® 3.7mm Compression screw L.32mm

213317S

Notched UNI-CLIP® interaxis 13 - L.17mm

131034S

BOLD® 3.7mm Compression screw L.34mm

213512S

Notched UNI-CLIP® interaxis 15 - L.12mm

QWIX® Fixation Screw, Dia. 3.0mm

213820S

Notched UNI-CLIP® interaxis 20 - L.20mm

Reference

Description

SOLUSTAPLE® Standard Staple

111312S

QWIX® screw dia. 3mm L.12mm

Reference

Description

111314S

QWIX® screw dia. 3mm L.14mm

114002S

SOLUSTAPLE® 90° width 8mm

111316S

QWIX® screw dia. 3mm L.16mm

114004S

SOLUSTAPLE® 90° width 10mm

111318S

QWIX® screw dia. 3mm L.18mm

114023S

SOLUSTAPLE® 26° width 8mm

114025S

SOLUSTAPLE® 26° width 10mm

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

BOLD® Compression Screw dia. 2.5 mm / 3.0 mm / 3.7 mm and QWIX® Fixation Screw dia. 3.0 mm Indications: For fixation of bone fractures or for bone reconstruction. Examples include: --Fixation of small bone fragments, in long bones or small bones fractures.

--Arthrodesis in hand or foot surgery --Mono or Bi-cortical osteotomies in the foot or hand --Distal or proximal metatarsal or metacarpal osteotomies --Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

CE 0120

forefoot

Complete Forefoot Set II - Sterile version

SPIN® Snap-off® Screw dia. 2.0 mm / 2.7mm Indications: For fixation of bone fractures or for bone reconstruction.Examples include: Weil osteotomy. Fixation of small bone fragments. Mono-cortical fixation. Osteotomies and fractures fixation in the foot and hand.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders.

UNI-CLIP® Compressive Staple Indications: For fixation of bone fractures or for bone reconstruction. Examples include: Arthrodesis in hand or foot surgery. Fractures management in the foot or hand.Mono or Bi-cortical osteotomies in the foot or hand. Distal or proximal metatarsal or metacarpal osteotomies. Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.).

The size of the chosen staple should be adapted to the specific indication.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation;Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders SOLUSTAPLE® Standard Staple Indications: For akin type osteotomya.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders.

Qwix® Fixation Screw dia. 3.0mm Indications: For fixation of bone fractures or for bone reconstruction. Examples include: -Mono or Bi-cortical osteotomies in the foot or hand (Hallux Valgus treatment). Fractures management in the foot or hand. Fixation of bone fragments in long bones or small bones fractures. Arthrodesis in hand, foot or ankle surgery. The size of the chosen screw should be adapted to the specific indication.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation. Active infection or inflammation.

Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who:. Lacks good general physical condition. Has severe osteoporosis. Demonstrates physiologic or anatomic anomalies. Has immunological responses, sensitization, or hypersensitivity to foreign materials. Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. BOLD is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. QWIX is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

SPIN is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

9

Forefoot

Complete Forefoot Set II - Non-sterile version

Compression Screws

Fixation Screws

Standard Staple

Compression Staple

Snap-Off screws

Bold®

QWIX®

Solustaple®

Uni-Clip®

Spin®

229991 INSTRUMENT TRAY Complete set - non sterile version Including: Reference

Description

229990

3 floors caddy

229970

Forefoot II lid

229961

Tray - screw ancillaries

229992

Mat - screws ancillaries

229962

Tray - staples ancillaries

229965

Tray - non sterile implants

229975

Rack - non sterile implants

: Available in spare part for replacement

10

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Instrumentation - screws module

Instrumentation - staples module

Reference

Description

Reference

Description

119105

BOLD® clamp

229201

UNI-CLIP® drilling guide

229002

Cannulated hexagonal screwdriver 2mm

229202

Impactor

229005

Cannulated hexagonal screwdriver AO tip 2mm

119311

UNI-CLIP® spreading forceps

229003

Cannulated screwdriver T7

229101

SOLUSTAPLE® drilling guide

229004

AO cannulated screwdriver T7

229102

SOLUSTAPLE® 26° and 90° impactor

229301

SPIN® screwdriver

997301

Depth gauge

997311

Straight AO handle

119307

UNI-CLIP® Depth Gauge

229101

SOLUSTAPLE® drilling guide

Drills & K-wires

997301

Depth gauge

Reference

Description

115100

K-wire dia. 1.0mm L.100mm - 2 sharps

Drills & K-wires Reference

Description

115070

K-wire dia. 1.0mm L.70mm - 1 sharp

119027

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

119006

Drill dia. 2.2mm L.41mm

119025

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

119004

Cannulated drill dia.2,2mm

119023

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

159027

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

159025

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

159023

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

119227

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.12mm

119225

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.22mm

119223

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.32mm

159227

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.12mm

159225

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.22mm

159223

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.32mm

115070

K-wire dia. 1.0mm L.70mm - 1 sharp

115100

K-wire dia. 1.0mm L.100mm - 2 sharps

229227S

BOLD® 2.5 « 2 in 1» cannulated drill L.12mm

229237S

BOLD® 2.5 « 2 in 1» cannulated drill L.22mm

229027S

BOLD® 2.5 « 2 in 1» cannulated drill L.12mm AO

229037S

BOLD® 2.5 « 2 in 1» cannulated drill L.22mm AO

229028S

BOLD® 2.5 « 2 in 1» non cannulated drill L.12mm AO

229038S

BOLD® 2.5 « 2 in 1» non cannulated drill L.22mm AO

229228S

BOLD® 2.5 « 2 in 1» non cannulated drill L.12mm

229238S

BOLD® 2.5 « 2 in 1» non cannulated drill L.22mm

115008S

K-wire dia. 0.8mm L.70mm - 1 sharp

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

forefoot

Forefoot

11

Forefoot

Implant BOLD® Compression Screw Dia. 2.5mm / 3.0mm / 3.7mm

12

Reference

Description

111322

QWIX® screw dia. 3mm L.22mm

200010

BOLD® 2.5mm Compression screw L.10mm

111324

QWIX® screw dia. 3mm L.24mm

200012

BOLD® 2.5mm Compression screw L.12mm

111326

QWIX® screw dia. 3mm L.26mm

200014

BOLD® 2.5mm Compression screw L.14mm

200016

BOLD® 2.5mm Compression screw L.16mm

111328

QWIX® screw dia. 3mm L.28mm

200018

BOLD® 2.5mm Compression screw L.18mm

111330

QWIX® screw dia. 3mm L.30mm

200020

BOLD® 2.5mm Compression screw L.20mm

111332

QWIX® screw dia. 3mm L.32mm

200022

BOLD® 2.5mm Compression screw L.22mm

111334

QWIX® screw dia. 3mm L.34mm

200024

BOLD® 2.5mm Compression screw L.24mm

SPIN® Snap-Off Screw, Dia. 2.0mm / 2.7mm

200026

BOLD® 2.5mm Compression screw L.26mm

Reference

Description

200028

BOLD® 2.5mm Compression screw L.28mm

112011

SPIN® screw dia. 2mm L.11mm

200030

BOLD® 2.5mm Compression screw L.30mm

112012

SPIN® screw dia. 2mm L.12mm

111010

BOLD® 3mm compression screw L.10mm

112013

SPIN® screw dia. 2mm L.13mm

111012

BOLD® 3mm compression screw L.12mm

112014

SPIN® screw dia. 2mm L.14mm

111014

BOLD® 3mm compression screw L.14mm

112111

SPIN® screw dia. 2.7mm L.11mm

111016

BOLD® 3mm compression screw L.16mm

112112

SPIN® screw dia. 2.7mm L.12mm

111018

BOLD® 3mm compression screw L.18mm

112113

SPIN® screw dia. 2.7mm L.13mm

111020

BOLD® 3mm compression screw L.20mm

112114

SPIN® screw dia. 2.7mm L.14mm

111022

BOLD® 3mm compression screw L.22mm

UNI-CLIP® Notched Staples

111024

BOLD® 3mm compression screw L.24mm

Reference

Description

111026

BOLD® 3mm compression screw L.26mm

213113

Notched UNI-CLIP® interaxis 11 - L.13mm

111028

BOLD® 3mm compression screw L.28mm

213114

Notched UNI-CLIP® interaxis 11 - L.14mm

111030

BOLD® 3mm compression screw L.30mm

213115

Notched UNI-CLIP® interaxis 11 - L.15mm

111032

BOLD® 3mm compression screw L.32mm

213116

Notched UNI-CLIP® interaxis 11 - L.16mm

111034

BOLD® 3mm compression screw L.34mm

213117

Notched UNI-CLIP® interaxis 11 - L.17mm

131014

BOLD® 3.7mm Compression screw L.14mm

213213

Notched UNI-CLIP® interaxis 12 - L.13mm

131016

BOLD® 3.7mm Compression screw L.16mm

213214

Notched UNI-CLIP® interaxis 12 - L.14mm

131018

BOLD® 3.7mm Compression screw L.18mm

213215

Notched UNI-CLIP® interaxis 12 - L.15mm

131020

BOLD® 3.7mm Compression screw L.20mm

213216

Notched UNI-CLIP® interaxis 12 - L.16mm

131022

BOLD® 3.7mm Compression screw L.22mm

213217

Notched UNI-CLIP® interaxis 12 - L.17mm

131024

BOLD® 3.7mm Compression screw L.24mm

213313

Notched UNI-CLIP® interaxis 13 - L.13mm

131026

BOLD® 3.7mm Compression screw L.26mm

213314

Notched UNI-CLIP® interaxis 13 - L.14mm

131028

BOLD® 3.7mm Compression screw L.28mm

213315

Notched UNI-CLIP® interaxis 13 - L.15mm

131030

BOLD® 3.7mm Compression screw L.30mm

213316

Notched UNI-CLIP® interaxis 13 - L.16mm

131032

BOLD® 3.7mm Compression screw L.32mm

213317

Notched UNI-CLIP® interaxis 13 - L.17mm

131034

BOLD® 3.7mm Compression screw L.34mm

213512

Notched UNI-CLIP® interaxis 15 - L.12mm

QWIX® Fixation Screw, Dia. 3.0mm

213820

Notched UNI-CLIP® interaxis 20 - L.20mm

Reference

Description

SOLUSTAPLE® Standard Staple

111312

QWIX® screw dia. 3mm L.12mm

Reference

Description

111314

QWIX® screw dia. 3mm L.14mm

114002

SOLUSTAPLE® 90° width 8mm

111316

QWIX® screw dia. 3mm L.16mm

114004

SOLUSTAPLE® 90° width 10mm

111318

QWIX® screw dia. 3mm L.18mm

114023

SOLUSTAPLE® 26° width 8mm

111320

QWIX® screw dia. 3mm L.20mm

114025

SOLUSTAPLE® 26° width 10mm

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

BOLD® Compression Screw dia. 2.5 mm / 3.0 mm / 3.7 mm Indications: For fixation of bone fractures or for bone reconstruction. Examples include: For fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments, in long bones or small bones fractures; Arthrodesis in hand or foot surgery; Mono or Bi-cortical osteotomies in the foot or hand; Distal or proximal metatarsal or metacarpal osteotomies; Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders.

SPIN® Snap-off® Screw dia. 2.0 mm / 2.7mm Indications: For fixation of bone fractures or for bone reconstruction.Examples include: Weil osteotomy. Fixation of small bone fragments. Mono-cortical fixation. Osteotomies and fractures fixation in the foot and hand.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

forefoot

Complete Forefoot Set II - Non-sterile version

CE 0120

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders.

UNI-CLIP® Compressive Staple Indications: For fixation of bone fractures or for bone reconstruction. Examples include: Arthrodesis in hand or foot surgery. Fractures management in the foot or hand.Mono or Bi-cortical osteotomies in the foot or hand. Distal or proximal metatarsal or metacarpal osteotomies. Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.).

The size of the chosen staple should be adapted to the specific indication.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation;Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders SOLUSTAPLE® Standard Staple Indications: For akin type osteotomya.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders.

Qwix® Fixation Screw dia. 3.0mm Indications: For fixation of bone fractures or for bone reconstruction. Examples include: -Mono or Bi-cortical osteotomies in the foot or hand (Hallux Valgus treatment). Fractures management in the foot or hand. Fixation of bone fragments in long bones or small bones fractures. Arthrodesis in hand, foot or ankle surgery. The size of the chosen screw should be adapted to the specific indication.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation. Active infection or inflammation.

Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who:. Lacks good general physical condition. Has severe osteoporosis. Demonstrates physiologic or anatomic anomalies. Has immunological responses, sensitization, or hypersensitivity to foreign materials. Systemic or metabolic disorders..

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. BOLD is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. QWIX is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

SPIN is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

13

Forefoot

Forefoot Set - Screw module - Sterile version

Compression Screws

Fixation Screws

Snap-Off screws

Bold®

QWIX®

Spin®

Screw instrumentation module

Implant SCREWS

14

BOLD® Compression Screw Dia. 2.5mm / 3.0mm / 3.7mm

131026S

BOLD® 3.7mm Compression screw L.26mm

Reference

Description

131028S

BOLD® 3.7mm Compression screw L.28mm

200010S

BOLD® 2.5mm Compression screw L.10mm

131030S

BOLD® 3.7mm Compression screw L.30mm

200012S

BOLD® 2.5mm Compression screw L.12mm

131032S

BOLD® 3.7mm Compression screw L.32mm

200014S

BOLD® 2.5mm Compression screw L.14mm

131034S

BOLD® 3.7mm Compression screw L.34mm

200016S

BOLD® 2.5mm Compression screw L.16mm

QWIX® Fixation Screw, Dia. 3.0mm

200018S

BOLD® 2.5mm Compression screw L.18mm

Reference

Description

200020S

BOLD® 2.5mm Compression screw L.20mm

111312S

QWIX® screw dia. 3mm L.12mm

200022S

BOLD® 2.5mm Compression screw L.22mm

111314S

QWIX® screw dia. 3mm L.14mm

200024S

BOLD® 2.5mm Compression screw L.24mm

111316S

QWIX® screw dia. 3mm L.16mm

200026S

BOLD® 2.5mm Compression screw L.26mm

111318S

QWIX® screw dia. 3mm L.18mm

200028S

BOLD® 2.5mm Compression screw L.28mm

111320S

QWIX® screw dia. 3mm L.20mm

200030S

BOLD® 2.5mm Compression screw L.30mm

111322S

QWIX® screw dia. 3mm L.22mm

111010S

BOLD® 3mm compression screw L.10mm

111012S

BOLD® 3mm compression screw L.12mm

111324S

QWIX® screw dia. 3mm L.24mm

111014S

BOLD® 3mm compression screw L.14mm

111326S

QWIX® screw dia. 3mm L.26mm

111016S

BOLD® 3mm compression screw L.16mm

111328S

QWIX® screw dia. 3mm L.28mm

111018S

BOLD® 3mm compression screw L.18mm

111330S

QWIX® screw dia. 3mm L.30mm

111020S

BOLD® 3mm compression screw L.20mm

111332S

QWIX® screw dia. 3mm L.32mm

111022S

BOLD® 3mm compression screw L.22mm

111334S

QWIX® screw dia. 3mm L.34mm

111024S

BOLD® 3mm compression screw L.24mm

SPIN® Snap-Off Screw, Dia. 2.0mm / 2.7mm

111026S

BOLD® 3.7mm Compression screw L.26mm

Reference

Description

111028S

BOLD® 3.7mm Compression screw L.28mm

112011S

SPIN® screw dia. 2mm L.11mm

111030S

BOLD® 3.7mm Compression screw L.30mm

112012S

SPIN® screw dia. 2mm L.12mm

111032S

BOLD® 3.7mm Compression screw L.32mm

111034S

BOLD® 3.7mm Compression screw L.34mm

112013S

SPIN® screw dia. 2mm L.13mm

131014S

BOLD® 3.7mm Compression screw L.14mm

112014S

SPIN® screw dia. 2mm L.14mm

131016S

BOLD® 3.7mm Compression screw L.16mm

112111S

SPIN® screw dia. 2.7mm L.11mm SPIN® screw dia. 2.7mm L.12mm

131018S

BOLD® 3.7mm Compression screw L.18mm

112112S

131020S

BOLD® 3.7mm Compression screw L.20mm

112113S

SPIN® screw dia. 2.7mm L.13mm

131022S

BOLD® 3.7mm Compression screw L.22mm

112114S

SPIN® screw dia. 2.7mm L.14mm

131024S

BOLD® 3.7mm Compression screw L.24mm

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

229963 INSTRUMENT TRAY Screw module - sterile version Including:

Reference

Description

119027S

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

119025S

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

119023S

BOLD® "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

159027S

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

159025S

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

Instrumentation

159023S

BOLD® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

Reference

Description

119227S

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.12mm

119105

BOLD® clamp

119225S

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.22mm

229002

Cannulated hexagonal screwdriver 2mm

119223S

BOLD® "2 in 1" drill dia. 2.2/3.0mm L.32mm

229005

Cannulated hexagonal screwdriver AO tip 2mm

159227S

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.12mm

159225S

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.22mm

159223S

BOLD® AO "2 in 1" drill dia. 2.2/3.0mm L.32mm

115070S

K-wire dia. 1.0mm L.70mm - 1 sharp

115100S

K-wire dia. 1.0mm L.100mm - 2 sharps

229227S

BOLD® 2.5 « 2 in 1» cannulated drill L.12mm

229237S

BOLD® 2.5 « 2 in 1» cannulated drill L.22mm

229027S

BOLD® 2.5 « 2 in 1» cannulated drill L.12mm AO

229037S

BOLD® 2.5 « 2 in 1» cannulated drill L.22mm AO

229028S

BOLD® 2.5 « 2 in 1» non cannulated drill L.12mm AO

229038S

BOLD® 2.5 « 2 in 1» non cannulated drill L.22mm AO

229228S

BOLD® 2.5 « 2 in 1» non cannulated drill L.12mm

229238S

BOLD® 2.5 « 2 in 1» non cannulated drill L.22mm

115008S

K-wire dia. 0.8mm L.70mm - 1 sharp

Reference

Description

229970

Forefoot II lid

229961

Screw base

229992

Mat screws ancillaries

: Available in spare part for replacement

229003

Cannulated screwdriver T7

229004

AO cannulated screwdriver T7

229301

SPIN® screwdriver

997311

Straight AO handle

229101

SOLUSTAPLE® drilling guide

997301

Depth gauge

forefoot

Drills & K-wires

Forefoot Set - Screw module - Sterile version BOLD® compression screw dia. 2.5mm/ 3.0mm/3.7mm Indications: The BOLD® SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Fixation of small bone fragments, in long bones or small bones fractures. -Arthrodesis in hand or foot surgery -Mono or Bi-cortical osteotomies in the foot or hand -Distal or proximal metatarsal or metacarpal osteotomies -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.).

Contraindications: The implant should not be used in a patient who has currently, or who has a history of:: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: - Lacks good general physical condition; - Has severe osteoporosis; - Demonstrates physiologic or anatomic anomalies; - Has immunological responses, sensitization, or hypersensitivity to foreign materials; - Systemic or metabolic disorders.

QWIX® fixation screw dia. 3.0mm Indications: The QWIX®® screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Mono or Bi-cortical osteotomies in the foot or hand (Hallux Valgus treatment…) -Fractures management in the foot or hand -Fixation of bone fragments in long bones or small bones fractures -Arthrodesis in hand, foot or ankle surgery The size of the chosen screw should be adapted to the specific indication.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

CE 0120

Contraindications: The implant should not be used in a patient who has currently, or who has a history of:: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who : -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials.

SPIN® Snap-off® Screw dia. 2.0 mm / 2.7mm Indications: For fixation of bone fractures or for bone reconstruction.Examples include: Weil osteotomy. Fixation of small bone fragments. Mono-cortical fixation. Osteotomies and fractures fixation in the foot and hand.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. BOLD is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. QWIX is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

SPIN is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

15

Forefoot

Forefoot Set - Screw module - Non-sterile version

Screw instrumentation module

Compression Screws

Fixation Screws

Snap-Off screws

Bold®

QWIX®

Spin®

Implant rack module

Implant SCREWS

16

BOLD® Compression Screw Dia. 2.5mm / 3.0mm / 3.7mm

131026

BOLD® 3.7mm Compression screw L.26mm

Reference

Description

131028

BOLD® 3.7mm Compression screw L.28mm

200010

BOLD® 2.5mm Compression screw L.10mm

131030

BOLD® 3.7mm Compression screw L.30mm

200012

BOLD® 2.5mm Compression screw L.12mm

131032

BOLD® 3.7mm Compression screw L.32mm

200014

BOLD® 2.5mm Compression screw L.14mm

131034

BOLD® 3.7mm Compression screw L.34mm

200016

BOLD® 2.5mm Compression screw L.16mm

QWIX® Fixation Screw, Dia. 3.0mm

200018

BOLD® 2.5mm Compression screw L.18mm

Reference

Description

200020

BOLD® 2.5mm Compression screw L.20mm

111312

QWIX® screw dia. 3mm L.12mm

200022

BOLD® 2.5mm Compression screw L.22mm

111314

QWIX® screw dia. 3mm L.14mm

200024

BOLD® 2.5mm Compression screw L.24mm

111316

QWIX® screw dia. 3mm L.16mm

200026

BOLD® 2.5mm Compression screw L.26mm

111318

QWIX® screw dia. 3mm L.18mm

200028

BOLD® 2.5mm Compression screw L.28mm

111320

QWIX® screw dia. 3mm L.20mm

200030

BOLD® 2.5mm Compression screw L.30mm

111322

QWIX® screw dia. 3mm L.22mm

111010

BOLD® 3mm compression screw L.10mm

111012

BOLD® 3mm compression screw L.12mm

111324

QWIX® screw dia. 3mm L.24mm

111014

BOLD® 3mm compression screw L.14mm

111326

QWIX® screw dia. 3mm L.26mm

111016

BOLD® 3mm compression screw L.16mm

111328

QWIX® screw dia. 3mm L.28mm

111018

BOLD® 3mm compression screw L.18mm

111330

QWIX® screw dia. 3mm L.30mm

111020

BOLD® 3mm compression screw L.20mm

111332

QWIX® screw dia. 3mm L.32mm

111022

BOLD® 3mm compression screw L.22mm

111334

QWIX® screw dia. 3mm L.34mm

111024

BOLD® 3mm compression screw L.24mm

SPIN® Snap-Off Screw, Dia. 2.0mm / 2.7mm

111026

BOLD® 3mm compression screw L.26mm

Reference

Description

111028

BOLD® 3mm compression screw L.28mm

112011

SPIN® screw dia. 2mm L.11mm

111030

BOLD® 3mm compression screw L.30mm

112012

SPIN® screw dia. 2mm L.12mm

111032

BOLD® 3mm compression screw L.32mm

111034

BOLD® 3mm compression screw L.34mm

112013

SPIN® screw dia. 2mm L.13mm

131014

BOLD® 3.7mm Compression screw L.14mm

112014

SPIN® screw dia. 2mm L.14mm

131016

BOLD® 3.7mm Compression screw L.16mm

112111

SPIN® screw dia. 2.7mm L.11mm SPIN® screw dia. 2.7mm L.12mm

131018

BOLD® 3.7mm Compression screw L.18mm

112112

131020

BOLD® 3.7mm Compression screw L.20mm

112113

SPIN® screw dia. 2.7mm L.13mm

131022

BOLD® 3.7mm Compression screw L.22mm

112114

SPIN® screw dia. 2.7mm L.14mm

131024

BOLD® 3.7mm Compression screw L.24mm

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

229951 INSTRUMENT TRAY Screw module - non sterile version Including: Reference

Description

229970

Forefoot II lid

229996

2 floors caddy

229965

Non Sterile Implants base

229975

Non Sterile Implants rack

229961

Screw base

229992

Mat screws ancillaries

: Available in spare part for replacement Instrumentation

Reference

Description

119027

Bold® "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

119025

Bold® "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

119023

Bold® "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

159027

Bold® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

159025

Bold® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.22mm

159023

Bold® AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.32mm

119227

Bold® "2 in 1" drill dia. 2.2/3.0mm L.12mm

119225

Bold® "2 in 1" drill dia. 2.2/3.0mm L.22mm

119223

Bold® "2 in 1" drill dia. 2.2/3.0mm L.32mm

159227

Bold® AO "2 in 1" drill dia. 2.2/3.0mm L.12mm

Reference

Description

159225

Bold® AO "2 in 1" drill dia. 2.2/3.0mm L.22mm

119105

BOLD® clamp

159223

Bold® AO "2 in 1" drill dia. 2.2/3.0mm L.32mm

229002

Cannulated hexagonal screwdriver 2mm

115070

K-wire dia. 1.0mm L.70mm - 1 sharp

229005

Cannulated hexagonal screwdriver AO tip 2mm

115100

K-wire dia. 1.0mm L.100mm - 2 sharps

229003

Cannulated screwdriver T7

229227S

Bold® 2.5 « 2 in 1» cannulated 1.8mm L.12mm

229004

AO cannulated screwdriver T7

229237S

Bold® 2.5 « 2 in 1» cannulated drill L.22mm

229301

SPIN® screwdriver

229027S

Bold® 2.5 « 2 in 1» cannulated drill L.12mm AO

997311

Straight AO handle

229037S

Bold® 2.5 « 2 in 1» cannulated drill L.22mm AO

229101

SOLUSTAPLE® drilling guide

229028S

Bold® 2.5 « 2 in 1» non cannulated drill L.12mm AO

997301

Depth gauge

229038S

Bold® 2.5 « 2 in 1» non cannulated drill L.22mm AO

229228S

Bold® 2.5 « 2 in 1» non cannulated drill L.12mm

229238S

Bold® 2.5 « 2 in 1» non cannulated drill L.22mm

115008S

K-wire dia. 0.8mm L.70mm - 1 sharp

forefoot

Drills & K-wires

Forefoot Set - Screw module - Non-sterile version BOLD® compression screw dia. 2.5mm/ 3.0mm/3.7mm Indications: The BOLD® SCREW is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Fixation of small bone fragments, in long bones or small bones fractures. -Arthrodesis in hand or foot surgery -Mono or Bi-cortical osteotomies in the foot or hand -Distal or proximal metatarsal or metacarpal osteotomies -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.).

Contraindications: The implant should not be used in a patient who has currently, or who has a history of:: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: - Lacks good general physical condition; - Has severe osteoporosis; - Demonstrates physiologic or anatomic anomalies; - Has immunological responses, sensitization, or hypersensitivity to foreign materials; - Systemic or metabolic disorders.

QWIX® fixation screw dia. 3.0mm Indications: The QWIX®® screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Mono or Bi-cortical osteotomies in the foot or hand (Hallux Valgus treatment…) -Fractures management in the foot or hand -Fixation of bone fragments in long bones or small bones fractures -Arthrodesis in hand, foot or ankle surgery The size of the chosen screw should be adapted to the specific indication.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

CE 0120

Contraindications: The implant should not be used in a patient who has currently, or who has a history of:: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who : -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials.

SPIN® Snap-off® Screw dia. 2.0 mm / 2.7mm Indications: For fixation of bone fractures or for bone reconstruction.Examples include: Weil osteotomy. Fixation of small bone fragments. Mono-cortical fixation. Osteotomies and fractures fixation in the foot and hand.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersentitivite to foreign materials; Systemic or metabolic disorders Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. BOLD is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. QWIX is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

SPIN is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa, and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018 DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

17

Forefoot

Forefoot Set - Staple module - Sterile version

Standard Staple

Compression Staple

Solustaple®

Uni-Clip®

Staple instrumentation module

Implant

229964 INSTRUMENT TRAY Staples module - sterile version Including:

STAPLES UNI-CLIP® Notched Staples Reference

Description

Reference

Description

229970

Forefoot II lid

229962

Staple base

213113S

Notched UNI-CLIP® interaxis 11 - L.13mm

213114S

Notched UNI-CLIP® interaxis 11 - L.14mm

Instrumentation

213115S

Notched UNI-CLIP® interaxis 11 - L.15mm

Reference

Description

213116S

Notched UNI-CLIP® interaxis 11 - L.16mm

229201

UNI-CLIP® drilling guide

213117S

Notched UNI-CLIP® interaxis 11 - L.17mm

229202

Impactor

213213S

Notched UNI-CLIP® interaxis 12 - L.13mm

119311

UNI-CLIP® spreading forceps

213214S

Notched UNI-CLIP® interaxis 12 - L.14mm

229101

SOLUSTAPLE® drilling guide

213215S

Notched UNI-CLIP® interaxis 12 - L.15mm

229102

SOLUSTAPLE® 26° and 90° impactor

213216S

Notched UNI-CLIP® interaxis 12 - L.16mm

997301

Depth gauge

213217S

Notched UNI-CLIP® interaxis 12 - L.17mm

119307

UNI-CLIP® Depth Gauge

213313S

Notched UNI-CLIP® interaxis 13 - L.13mm

Drills & K-wires

213314S

Notched UNI-CLIP® interaxis 13 - L.14mm

Reference

Description

213315S

Notched UNI-CLIP® interaxis 13 - L.15mm

115100S

K-wire dia. 1.0mm L.100mm - 2 sharps

213316S

Notched UNI-CLIP® interaxis 13 - L.16mm

115070S

K-wire dia. 1.0mm L.70mm - 1 sharp

213317S

Notched UNI-CLIP® interaxis 13 - L.17mm

119006S

Drill dia. 2.2mm L.41mm

213512S

Notched UNI-CLIP® interaxis 15 - L.12mm

119004S

Cannulated drill dia.2,2mm

213820S

Notched UNI-CLIP® interaxis 20 - L.20mm

SOLUSTAPLE® Standard Staple Reference

Description

114002S

SOLUSTAPLE® 90° width 8mm

114004S

SOLUSTAPLE® 90° width 10mm

114023S

SOLUSTAPLE® 26° width 8mm

114025S

SOLUSTAPLE® 26° width 10mm

: Available in spare part for replacement

18

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

forefoot

Forefoot

Forefoot Set - Staple module - Sterile version UNI-CLIP® notched compression staples Indications: The UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Arthrodesis in hand or foot surgery -Fractures management in the foot or hand -Mono or Bi-cortical osteotomies in the foot or hand -Distal or proximal metatarsal or metacarpal osteotomies -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) The size of the chosen staple should be adapted to the specific indication.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials; -Systemic or metabolic disorders.

SOLUSTAPLE® standard staple Indications: The SOLUSTAPLE® is indicated for : -Akin type osteotomya

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

CE 0120

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials; -Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. SOLUSTAPLE is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. wUni-Clip is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

19

Forefoot

Forefoot Set - Staple module - Non-sterile version

Standard Staple

Compression Staple

Solustaple®

Uni-Clip®

Staple instrumentation module

Implant

229952 INSTRUMENT TRAY Staples module - non sterile version Including:

STAPLES UNI-CLIP® Notched Staples Reference

Description

213113

Notched UNI-CLIP® interaxis 11 - L.13mm

213114

Notched UNI-CLIP® interaxis 11 - L.14mm

213115

Notched UNI-CLIP® interaxis 11 - L.15mm

213116

Notched UNI-CLIP® interaxis 11 - L.16mm

213117

Notched UNI-CLIP® interaxis 11 - L.17mm

213213

Notched UNI-CLIP® interaxis 12 - L.13mm

213214

Notched UNI-CLIP® interaxis 12 - L.14mm

213215

Notched UNI-CLIP® interaxis 12 - L.15mm

213216

Notched UNI-CLIP® interaxis 12 - L.16mm

213217

Notched UNI-CLIP® interaxis 12 - L.17mm

213313

Notched UNI-CLIP® interaxis 13 - L.13mm

213314

Notched UNI-CLIP® interaxis 13 - L.14mm

213315

Notched UNI-CLIP® interaxis 13 - L.15mm

213316

Notched UNI-CLIP® interaxis 13 - L.16mm

213317

Notched UNI-CLIP® interaxis 13 - L.17mm

213512

Notched UNI-CLIP® interaxis 15 - L.12mm

213820

Implant rack module

Notched UNI-CLIP® interaxis 20 - L.20mm

SOLUSTAPLE® Standard Staple Reference

Description

114002

SOLUSTAPLE® 90° width 8mm

114004

SOLUSTAPLE® 90° width 10mm

114023

SOLUSTAPLE® 26° width 8mm

114025

SOLUSTAPLE® 26° width 10mm

Reference

Description

229970

Forefoot II lid

229996

2 floors caddy

229962

Staples base ancillaries

229965

Non sterile implants base

229975

Non sterile implants tray

Instrumentation Reference

Description

229201

UNI-CLIP® drilling guide

229202

Impactor

119311

UNI-CLIP® spreading forceps

229101

SOLUSTAPLE® drilling guide

229102

SOLUSTAPLE® 26° and 90° impactor

997301

Depth gauge

119307

UNI-CLIP® Depth Gauge

Drills & K-wires Reference

Description

115100

K-wire dia. 1.0mm L.100mm - 2 sharps

115070

K-wire dia. 1.0mm L.70mm - 1 sharp

119006

Drill dia. 2.2mm L.41mm

119004

Cannulated drill dia.2,2mm

: Available in spare part for replacement

20

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

forefoot

Forefoot

Forefoot Set - Staple module - Non-sterile version UNI-CLIP® notched compression staples Indications: The UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Arthrodesis in hand or foot surgery -Fractures management in the foot or hand -Mono or Bi-cortical osteotomies in the foot or hand -Distal or proximal metatarsal or metacarpal osteotomies -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) The size of the chosen staple should be adapted to the specific indication.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials; -Systemic or metabolic disorders.

SOLUSTAPLE® standard staple Indications: The SOLUSTAPLE® is indicated for : -Akin type osteotomya

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

CE 0120

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials; -Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. SOLUSTAPLE is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. Uni-Clip is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

21

Forefoot

Drills Drill Reference

Corresponding product

2 in 1

Diameter

Cannulated

Length

159 027 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

12 mm

159 025 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

22 mm

159 023 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

32 mm

119 227 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

12 mm

119 225 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

22 mm

119 223 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

32 mm

119 027 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

12 mm

119 025 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

22 mm

119 023 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

32 mm

159 227 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

12 mm

159 225 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

22 mm

159 223 (S)

BOLD® 3.0 / BOLD® 3.7

2.2 - 3.0 mm

32 mm

229 027 S

BOLD® 2.5

1.9 - 2.5 mm

12 mm

229 037 S

BOLD® 2.5

1.9 - 2.5 mm

22 mm

229 227 S

BOLD® 2.5

1.9 - 2.5 mm

12 mm

229 237 S

BOLD® 2.5

1.9 - 2.5 mm

22 mm

229 028 S

BOLD® 2.5

1.9 - 2.5 mm

12 mm

229 038 S

BOLD® 2.5

1.9 - 2.5 mm

22 mm

229 228 S

BOLD® 2.5

1.9 - 2.5 mm

12 mm

229 238 S

BOLD® 2.5

1.9 - 2.5 mm

22 mm

119 004 (S)

Uni-Clip®

2.2 mm

34 mm

119 006 (S)

Uni-Clip®

2.2 mm

34 mm

159 004 (S)

Uni-Clip®

2.2 mm

34 mm

119 016 (S)

Uni-Clip®

2.2 mm

34 mm

AO attachment

All drills are delivered sterile or non sterile except Bold® 2.5 drills which are only delivered in sterile.

S: only in sterile (S): available in sterile and non sterile version. Remove the S for non sterile version.

22

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

K-wires K-wire Reference

Corresponding product

Diameter

Length

115 070 (S) 115 100 (S)

BOLD® 3.0 / BOLD® 3.7 / Uni-Clip® BOLD® 3.0 / BOLD® 3.7 / Uni-Clip®

1.0 mm 1.0 mm

70 mm 100 mm

BOLD® 2.5

0.8 mm

70 mm

115 008 S

All K-wires are delivered sterile or non sterile except Bold® 2.5 K-wire which is only delivered in sterile.

forefoot

S: only in sterile (S): available in sterile and non sterile version. Remove the S for non sterile version.

Forefoot Set - Drills & K-wires K-Wires Indications: The K WIRES are indicated for use: In fixation of bone fractures, for bone reconstruction, as guide pins for insertion of other implants. The size of the K WIRE chosen should be adapted to the specific indication.

Bold® Screws Indications: For fixation of bone fractures or for bone reconstruction. Examples include: Fixation of small bone fragments, in long bones or small bones fractures ; Arthrodesis in hand or foot surgery ; Mono or Bi-cortical osteotomies in the foot or hand ; Distal or proximal metatarsal or metacarpal osteotomies ; Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.).

Uni-Clip® staples Indications: The UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Arthrodesis in hand or foot surgery -Fractures management in the foot or hand -Mono or Bi-cortical osteotomies in the foot or hand -Distal or proximal metatarsal or metacarpal osteotomies -Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) The size of the chosen staple should be adapted to the specific indication.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33 (0)4.37.47.51.51 office • +33 (0)4.37.47.51.52 fax

CE 0120

Bold screws and Uni-Clip staples and K-Wires Contraindications: The implant should not be used in a patient who has currently, or who has a history of: Local or systemic acute or chronic inflammation; Active infection or inflammation; Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: Lacks good general physical condition; Has severe osteoporosis; Demonstrates physiologic or anatomic anomalies; Has immunological responses, sensitization, or hypersensitivity to foreign materials; Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Uni-Clip, Bold, Integra and the Integra logo are registered trademarks of Integra Lifesciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class IIa, and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

23

Forefoot

Osteoguides Transversal osteotomy guide

•

•

Suggested use: >> Scarf osteotomy. >> Chevron osteotomy. >> Basal osteotomy. >> Arthrodesis. >> Wedge osteotomies (Akin…).

Details: >> Hole for K-Wire: Diameter 1.0 to 1.6 mm. >> Knurled handle for optimal grip. >> Blade thickness maxi 0.8 mm. >> Positioning tip.

Reference

Description

229011

Longitudinal

229012

Transversal

Longitudinal osteotomy guide

Osteoguides Products mentioned in this document are CE class I devices. Please contact Integra customer service should you need any additional information on devices classification.

Integra is registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries.

Indications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Newdeal and Surfix® products ranges. None of the instruments should be implanted. Only medical professionals who are thoroughly familiar with the instruments function, application, and use should use them in surgery. Only a surgeon qualified to perform the orthopedic surgery required by the particular patient should use the surgical instruments Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

24

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

Forefoot

Removal instruments for forefoot set implants (Bold® dia 2.5 mm, dia. 3.0 mm, dia 3.7 mm compression screws; Qwix® dia.3.0 mm fixation screw; Spin® snap-off screws dia. 2.0 mm and 2.7 mm).

K-wires Reference

Description

115070

K-wire dia. 1.0mm L.70mm - 1 sharp

115008S

K-wire dia. 0.8mm L.70mm - 1 sharp

Instrumentation Description

229003

Cannulated screwdriver T7

229004

AO cannulated screwdriver T7

229002

Cannulated hexagonal screwdriver 2mm

229005

Cannulated hexagonal screwdriver AO tip 2mm

229301

Spin® screwdriver

forefoot

Reference

Removal instruments for forefoot set implants (Bold® dia 2.5 mm, dia. 3.0 mm, dia 3.7 mm compression screws; Qwix® dia.3.0 mm fixation screw; Spin® snap-off screws dia. 2.0 mm and 2.7 mm) Products mentioned in this document are CE class I, IIa, IIb devices. Please contact Integra customer service should you need any additional information on devices classification. Integra, Bold, Spin and Qwix are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries.

Indications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Newdeal and Surfix® products ranges. None of the instruments should be implanted. Only medical professionals who are thoroughly familiar with the instruments function, application, and use should use them in surgery. Only a surgeon qualified to perform the orthopedic surgery required by the particular patient should use the surgical instruments. Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff. These devices do not contain phtalates unless this is indicated on the label.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

CE 0120

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

25

Forefoot

Ti6™ TC Low-Profile bone screws Associated instrumentation:

• Cannulated, threaded bone screws.

• 4 diameters: 2.0, 2.5, 3.0, and 4.0 mm.

+ Base Intruments

TC Series Cannulated low profile screws

Implants Reference

Description

Ti6™ TC Low-Profile bone screws

26

TC2006

Ti6 Low Profile 2.0mm x 6mm Bone Screw

TC3036

Ti6 Low Profile 3.0mm x 36mm Bone Screw

TC2008

Ti6 Low Profile 2.0mm x 8mm Bone Screw

TC3040

Ti6 Low Profile 3.0mm x 40mm Bone Screw

TC2010

Ti6 Low Profile 2.0mm x 10mm Bone Screw

TC4012

Ti6 Low Profile 4.0mm x 12mm Bone Screw

TC2012

Ti6 Low Profile 2.0mm x 12mm Bone Screw

TC4014

Ti6 Low Profile 4.0mm x 14mm Bone Screw

TC2014

Ti6 Low Profile 2.0mm x 14mm Bone Screw

TC4016

Ti6 Low Profile 4.0mm x 16mm Bone Screw

TC2016

Ti6 Low Profile 2.0mm x 16mm Bone Screw

TC4018

Ti6 Low Profile 4.0mm x 18mm Bone Screw

TC2018

Ti6 Low Profile 2.0mm x 18mm Bone Screw

TC4020

Ti6 Low Profile 4.0mm x 20mm Bone Screw

TC2020

Ti6 Low Profile 2.0mm x 20mm Bone Screw

TC4022

Ti6 Low Profile 4.0mm x 22mm Bone Screw

TC2022

Ti6 Low Profile 2.0mm x 22mm Bone Screw

TC4024

Ti6 Low Profile 4.0mm x 24mm Bone Screw

TC2508

Ti6 Low Profile 2.5mm x 8mm Bone Screw

TC4026

Ti6 Low Profile 4.0mm x 26mm Bone Screw

TC2510

Ti6 Low Profile 2.5mm x 10mm Bone Screw

TC4028

Ti6 Low Profile 4.0mm x 28mm Bone Screw

TC2512

Ti6 Low Profile 2.5mm x 12mm Bone Screw

TC4030

Ti6 Low Profile 4.0mm x 30mm Bone Screw

TC2514

Ti6 Low Profile 2.5mm x 14mm Bone Screw

TC4032

Ti6 Low Profile 4.0mm x 32mm Bone Screw

TC2516

Ti6 Low Profile 2.5mm x 16mm Bone Screw

TC4034

Ti6 Low Profile 4.0mm x 34mm Bone Screw

TC2518

Ti6 Low Profile 2.5mm x 18mm Bone Screw

TC4036

Ti6 Low Profile 4.0mm x 36mm Bone Screw

TC2520

Ti6 Low Profile 2.5mm x 20mm Bone Screw

TC4038

Ti6 Low Profile 4.0mm x 38mm Bone Screw

TC2522

Ti6 Low Profile 2.5mm x 22mm Bone Screw

TC4040

Ti6 Low Profile 4.0mm x 40mm Bone Screw

TC2524

Ti6 Low Profile 2.5mm x 24mm Bone Screw

TC4042

Ti6 Low Profile 4.0mm x 42mm Bone Screw

TC2526

Ti6 Low Profile 2.5mm x 26mm Bone Screw

TC4046

Ti6 Low Profile 4.0mm x 46mm Bone Screw

TC2528

Ti6 Low Profile 2.5mm x 28mm Bone Screw

TC4050

Ti6 Low Profile 4.0mm x 50mm Bone Screw

TC2530

Ti6 Low Profile 2.5mm x 30mm Bone Screw

TC3010

Ti6 Low Profile 3.0mm x 10mm Bone Screw

TC3012

Ti6 Low Profile 3.0mm x 12mm Bone Screw

TC3014

Ti6 Low Profile 3.0mm x 14mm Bone Screw

TC3016

Ti6 Low Profile 3.0mm x 16mm Bone Screw

TC3018

Ti6 Low Profile 3.0mm x 18mm Bone Screw

TC3020

Ti6 Low Profile 3.0mm x 20mm Bone Screw

TC3022

Ti6 Low Profile 3.0mm x 22mm Bone Screw

TC3024

Ti6 Low Profile 3.0mm x 24mm Bone Screw

TC3026

Ti6 Low Profile 3.0mm x 26mm Bone Screw

TC3028

Ti6 Low Profile 3.0mm x 28mm Bone Screw

TC3030

Ti6 Low Profile 3.0mm x 30mm Bone Screw

TC3032

Ti6 Low Profile 3.0mm x 32mm Bone Screw

TC3034

Ti6 Low Profile 3.0mm x 34mm Bone Screw

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

Instruments Description

FS3010

TC Series 2.0 / 2.5mm Cann. Driver Shaft

FS3020

TC Series 3.0 / 4.0mm Cann. Driver Shaft

FS3030

TC Series Cann. Depth Gauge & Csink For 2.0 / 2.5mm Screws

FS3040

TC Series Cann. Depth Gauge & Csink For 3.0 / 4.0mm Screws

FS3042

2.0/2.5 Cann. Drill 1.65mm

FS3050

TC Series Cann. Over Drill For 3.0 / 4.0mm Screws

TT3000

TC Series Instrument Sterilization Tray

TT3000L

TC Instrument Tray Lid

KW1102

Ti6 Tc Series Kwire 2.0/2.5 (0.9 x 100mm)

KW1103

Ti6 Tc Series Kwire 3.0/4.0 (1.1 x 120mm)

KW1104

Ti6 Tc Series Thrd Kwire 3.0/4.0 (1.1 x 120mm)

forefoot

Reference

Ti6™ TC Low-Profile bone screws Indications: The Ti6™ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

All Ti6™ implants and guide wires are intended for single use only. Please note that any single use device (SUD) which comes into contact with human blood or tissue should not be re-used and should be decontaminated before returning it to the manufacturer or properly disposed of according to hospital procedure.

Contraindications: Use of the Ti6™ Internal Fixation System is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously sensitized to titanium; or in patients with certain metabolic diseases. It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of internal fixation.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, Texas 78758 USA Phone: 1 (800) 654-2873 Fax: 1 (888) 980-7742

CE 0086 Integra LifeSciences Services (France) S.A.S. Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France Phone: +33(0)4 37 47 59 50 Fax: +33(0)4 37 47 59 30

All the references numbers mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

27

Forefoot

Ti6™ TH Headless bone screws (TH-Series) Associated instrumentation:

• Cannulated, Cannulated, dual-thread, headless bone screws.

• 2 diameters: 2.5mm and 3.0mm.

+ Ti6TM TH-TQ- series instruments

Base Intruments Implants Reference

Instruments Reference

Description

Ti6™ TH Low-Profile bone screws

Description

FS4010

TH Series Cann. Driver Shaft

TH2510

Ti6 Headless 2.5mm x 10mm Bone Screw

FS4020

TH Series Cann. Depth Gauge

TH2512

Ti6 Headless 2.5mm x 12mm Bone Screw

FS4030

TH Series Cann. Relief Drill

TH2514

Ti6 Headless 2.5mm x 14mm Bone Screw

FS4040

TH Series Removal Driver Shaft

TH2516

Ti6 Headless 2.5mm x 16mm Bone Screw

FS5010

TQ Series Quicksnap 3Prong Driver Shaft

TH2518

Ti6 Headless 2.5mm x 18mm Bone Screw

TT4000L

TH Instrument Tray Lid

TH2520

Ti6 Headless 2.5Mm x 20mm Bone Screw

TT4000S

TH2522

Ti6 Headless 2.5mm x 22mm Bone Screw

TH & Tq Series Instrument Sterilization Tray With TQ27xx Cavity

TH3014

Ti6 Headless 3.0mm x 14mm Bone Screw

KW1105

Ti6 TH Series Kwire (0.80 x 70mm)

TH3016

Ti6 Headless 3.0mm x 16mm Bone Screw

TH3018

Ti6 Headless 3.0mm x 18mm Bone Screw

TH3020

Ti6 Headless 3.0mm x 20mm Bone Screw

TH3022

Ti6 Headless 3.0mm x 22mm Bone Screw

TH3024

Ti6 Headless 3.0mm x 24mm Bone Screw

TH3026

Ti6 Headless 3.0mm x 26mm Bone Screw

TH3028

Ti6 Headless 3.0mm x 28mm Bone Screw

TH3030

Ti6 Headless 3.0mm x 30mm Bone Screw

TH3032

Ti6 Headless 3.0mm x 32mm Bone Screw

TH3034

Ti6 Headless 3.0mm x 34mm Bone Screw

Ti6™ TH Low-Profile bone screws Indications: The Ti6™ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

All Ti6™ implants and guide wires are intended for single use only. Please note that any single use device (SUD) which comes into contact with human blood or tissue should not be re-used and should be decontaminated before returning it to the manufacturer or properly disposed of according to hospital procedure.

Contraindications: Use of the Ti6™ Internal Fixation System is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously sensitized to titanium; or in patients with certain metabolic diseases. It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of internal fixation.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the references numbers mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

28

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, Texas 78758 USA Phone: 1 (800) 654-2873 Fax: 1 (888) 980-7742

CE 0086 Integra LifeSciences Services (France) S.A.S. Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France Phone: +33(0)4 37 47 59 50 Fax: +33(0)4 37 47 59 30

Forefoot

Ti6™ TQ Quick-Snap screws (TQ-Series) Associated instrumentation:

• Snap-off solid core screws.

• 2 diameters: 2.0 mm and 2.7 mm.

+ Base Intruments

Reference

Instruments Reference

Description

Ti6™ TQ Low-Profile bone screws

Description

FS4010

TH Series Cann. Driver Shaft

TQ2008

Ti6 Quicksnap 2.0mm x 8mm Screw

FS4020

TH Series Cann. Depth Gauge

TQ2010

Ti6 Quicksnap 2.0mm x 10mm Screw

FS4030

TH Series Cann. Relief Drill

TQ2011

Ti6 Quicksnap 2.0mm x 11mm Screw

FS4040

TH Series Removal Driver Shaft

TQ2012

Ti6 Quicksnap 2.0mm x 12mm Screw

FS5010

TQ Series Quicksnap 3Prong Driver Shaft

TQ2014

Ti6 Quicksnap 2.0mm x 14mm Screw

TT4000L

TH Instrument Tray Lid

TQ2016

Ti6 Quicksnap 2.0mm x 16mm Screw

TT4000S

TQ2712

Ti6 Quicksnap 2.7mm x 12mm Screw

TH & Tq Series Instrument Sterilization Tray With TQ27xx Cavity

TQ2714

Ti6 Quicksnap 2.7mm x 14mm Screw

KW1105

Ti6 TH Series Kwire (0.80 x 70mm)

TQ2716

Ti6 Quicksnap 2.7mm x 16mm Screw

TQ2718

Ti6 Quicksnap 2.7mm x 18mm Screw

TQ2720

Ti6 Quicksnap 2.7mm x 20mm Screw

TQ2722

Ti6 Quicksnap 2.7mm x 22mm Screw

forefoot

Implants

Ti6TM TH-TQ- series instruments

Ti6™ TQ Low-Profile bone screws Indications: The Ti6™ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

All Ti6™ implants and guide wires are intended for single use only. Please note that any single use device (SUD) which comes into contact with human blood or tissue should not be re-used and should be decontaminated before returning it to the manufacturer or properly disposed of according to hospital procedure.

Contraindications: Use of the Ti6™ Internal Fixation System is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously sensitized to titanium; or in patients with certain metabolic diseases. It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of internal fixation.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, Texas 78758 USA Phone: 1 (800) 654-2873 Fax: 1 (888) 980-7742

CE 0086 Integra LifeSciences Services (France) S.A.S. Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France Phone: +33(0)4 37 47 59 50 Fax: +33(0)4 37 47 59 30

All the references numbers mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

29

Forefoot

Ti6™ Base Instruments To be used with both TC-Series instruments and TH-Series & TQ-Series instruments

Instruments Reference

Description

FS1005

Titanium Swivel Driver Handle

FS1006

Ratchet Driver Handle, Blue

FS1010

Bone Reduction Forceps Sweetheart Style

FS1012

Bone Reduction Forceps Serrated

FS1014

Bone Reduction Forceps Scarf

FS1030

Screw Pickup Forceps

FS1040

Screw Removal Tool

TT1000

Base Instrument Sterilization Tray

TT1000L

Base Instrument Tray Lid

Ti6™ Base instruments Indications: The Ti6™ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

All Ti6™ implants and guide wires are intended for single use only. Please note that any single use device (SUD) which comes into contact with human blood or tissue should not be re-used and should be decontaminated before returning it to the manufacturer or properly disposed of according to hospital procedure.

Contraindications: Use of the Ti6™ Internal Fixation System is contraindicated in cases of active or suspected infection or in patients who are immunocompromised; in patients previously sensitized to titanium; or in patients with certain metabolic diseases. It is further contraindicated in patients exhibiting disorders which would cause the patient to ignore the limitations of internal fixation.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the references numbers mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

30

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Ascension Orthopedics, Inc. 11101 Metric Blvd Austin, Texas 78758 USA Phone: 1 (800) 654-2873 Fax: 1 (888) 980-7742

CE 0086 Integra LifeSciences Services (France) S.A.S. Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France Phone: +33(0)4 37 47 59 50 Fax: +33(0)4 37 47 59 30

forefoot

Forefoot

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

31

Forefoot

K-FIX® – K-Wire End Protector K-FIX® Reference

Description

119050

K-FIX® wire end protector (5 units per pack)

K-FIX® – K-Wire End Protector Indications: The wire protecting caps are indicated for use in: Fractures of the metatarsals, tarse and phalanges - Osteotomies and arthrodesis in the forefoot - Fractures of the digiti, metacarpals, carpe and scafoid - Arthrodesis of the digiti.

Contraindications: Themedical device should not be used in a patient who has currently, or who has history of: Local or systemic acute or chronic inflammation - Active infection or inflammation - Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of themedical device in a patient who: Lacks good general physical condition - Has severe osteoporosis - Demonstrates physiologic or anatomic anomalies - Has immunological responses, sensitisation, or hypersensitivity to foreign materials - Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

K-FIX is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Products mentioned in this document are CE Class Is devices. Please contact Integra customer service should you need any additional information on devices classification.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

32

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

CE 0120

Forefoot

IPP-ON® anatomic proximal interphalangeal joint fusion implant Implant Reference

Description

230001S

Interphalangeal implant size 1

230002S

Interphalangeal implant size 2

Instrument Reference

Description

CONTAINER 239000

Instruments tray for IPP-ON®

239001

Basis

996100

Lid standard

278902

Mat

119909

4 Blue silicone wedges

forefoot

Including the following components:

INSTRUMENTATION 239011

Distal PIP Fusion hand drill - Size 1

239012

Proximal PIP Fusion hand drill - Size 1

239021

Distal PIP Fusion hand drill - Size 2

239022

Proximal PIP Fusion hand drill - Size 2

239500

Clamp holder

239030

PIP Fusion handle holder

IPP-ON® Interphalangeal Arthrodesis Implant Indications: The IPP-ON® implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: -rigid or semi-rigid hammertoe deformity -revision of failed arthroplasty or arthrodesis -2nd toe shortening. Use x-rays to ensure that implant is able to be adapted to the joint concerned. In the case of corticals which are too thin, a diaphysis which is very wide or too narrow, a very soft or hard bone, implantation of this implant is not recommended.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Active local or systemic infection -Severe peripheral vascular disease -Severe longitudinal deformity -Insufficient quantity or quality of bone to permit stabilization of the arthrodesis -Conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process -Suspected or documented metal allergy or intolerance. Use x-rays to ensure that implant is able to be adapted to the joint concerned. In the case of corticals which are too thin, a diaphysis which is very wide or too narrow, a very soft or hard bone, implantation of this implant is not recommended Warnings: Serious post-operative complications may occur from use of the implant in a patient who: --Lacks good general physical condition; --Has severe osteoporosis; --Demonstrates physiologic or anatomic anomalies; --Has immunological responses, sensitization, or hypersensitivity to foreign materials; --Systemic or metabolic disorders. These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue.

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

CE 0120

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. IPP-ON is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Products mentioned in this document are CE class I, IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

33

Forefoot

K2™ Hemi Toe Implant Plates Reference

Description

201010

K2 Hemi Toe Implant, Size 1

201020

K2 Hemi Toe Implant, Size 2

201030

K2 Hemi Toe Implant, Size 3

201040

K2 Hemi Toe Implant, Size 4

Instruments Reference

Description

202010KMI

Size 1 trial

202 020

Size 2 trail

202 030

Size 3 trial

202 040

Size 4 trial

203 010

Size 1 shaper

203 020

Size 2 shaper

203 030

Size 3 shaper

203 040

Size 4 shaper

203 100

Cutting guide

203 300

Sizer/drill guide

203 500

Broach handle

203 600

Impactor

205000KMI

Sterilization tray

Instruments Single Use Reference

Description

203 200

Reamer

203 415

1.5mm 80mm drill bit

K2™ Hemi Toe Implant Indications: The K2 Hemi is indicated for use in patients suffering from pain and/or loss of function due to : - Osteoarthritis of the first metatarsophalangeal joint.

- Trauma involving the first metatarsophalangeal joint. -Hallux rigidus with degenerative joint disease.

- Hallux valgus associated with arthritis.

The K2 Hemi may also be indicated for use in the revision of a failed implant, in younger patients with articular joint disease, or in difficult situations where clinical experience indicates that other reconstructive efforts are likely to achieve unsatisfactory results. Use should be limited to those conditions where preoperative exam indicates sufficient bone stock for the support of the implant.

Contraindications: Contraindications for the use of the K2 Hemi include any condition, which would contraindicate the use of joint replacement in general, including: - Poor bone quality, which may affect the stability of the implant.

- Severe tendon, neurological, or vascular deficiencies, which could compromise the affected extremity.

- Any concomitant disease, which may compromise the function of the implants.

- Active Infection. -Rheumatoid arthritis.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. K2 is a trademark of Integra LifeSciences Corporation.

Class I; Class IIa; Class IIb. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Last revision date: 04/2018.

34

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Integra LifeSciences Corporation 4900 Charlemar Drive Building A Cincinnati - OH 45227 - USA

CE 0120 Integra LifeSciences Services (France) S.A.S. Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France Phone: +33(0)4 37 47 59 50 Fax: +33(0)4 37 47 59 30

forefoot

Forefoot

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

Movementâ„¢ great toe system Implant Reference

Description

MGT-890-10PPH

Hemi Proximal Phalanx, Size 10

MGT-890-20PPH

Hemi Proximal Phalanx, Size 20

MGT-890-30PPH

Hemi Proximal Phalanx, Size 30

MGT-890-40PPH

Hemi Proximal Phalanx, Size 40

MGT-890-10PPT

Phalangeal Total, Size 10

MGT-890-20PPT

Phalangeal Total, Size 20

MGT-890-30PPT

Phalangeal Total, SiZe 30

MGT-890-40PPT

Phalangeal Total, Size 40

MGT-890-10MT

Hemi Metatarsal, Size 10

MGT-890-20MT

Hemi Metatarsal, Size 20

MGT-890-30MT

Hemi Metatarsal, Size 30

MGT-890-40MT

Hemi Metatarsal, Size 40

Instruments

36

Reference

Description

MIS-890-00

Metatarsal Implant sizer

PIS-890-00

Proximal Phalanx implant sizer

GDW-890-00

2.0mm X 125mm Guide pin

MSR-890-10/20

Metatarsal surface reamer size 10/20

MSR-890-30/40

Metatarsal surface reamer size 30/40

PSR-890-10/20

Proximal Phalanx surface reamer size 10/20

PSR-890-30/40

Proximal Phalanx surface reamer size 30/40

DRL-890-00

4.5mm cannulated Drill

DCG-890-00

Metatarsal Dorsal Cut Guide

IMP-890-00MT

Metatarsal Impactor

IMP-890-00PP

Proximal Phalanx Impactor

ALG-890-00

Sizer Alignment Guide

PPB-890-00

Proximal Phalanx Broach

TRL-890-10MT

Metatarsal Trial Size 10

TRL-890-20MT

Metatarsal Trial Size 20

TRL-890-30MT

Metatarsal Trial Size 30

TRL-890-40MT

Metatarsal Trial Size 40

TRL-890-10PPH

Proximal Phalanx Hemi Trial Size 10

TRL-890- 20PPH

Proximal Phalanx Hemi Trial Size 20

TRL-890- 30PPH

Proximal Phalanx Hemi Trial Size 30

TRL-890- 40PPH

Proximal Phalanx Hemi Trial Size 40

TRL-890-10PPT

Proximal Phalanx Total Trial Size 10

TRL-890- 20PPT

Proximal Phalanx Total Trial Size 20

TRL-890- 30PPT

Proximal Phalanx Total Trial Size 30

TRL-890- 40PPT

Proximal Phalanx Total Trial Size 40

CSA-000-14

Generic Case Lid per

CSA-890-10

MGT Base (Case)

CSA-890-11

MGT Trial Caddy

CSA-890-12

MGT Base Caddy Lid

: Available in spare part for replacement

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

forefoot

Forefoot

Movement™ great toe system Indications: Hemi-Arthroplasty: The Movement™ Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The components are anatomically designed, unconstrained and monolithic devices. The devices are made from cobalt chromium alloy meeting ASTM F1537 or ASTM F75 with a commercially pure titanium plasma spray meeting ASTM F1580. Indications include: • Hallux valgus or Hallux limitus, • Hallux rigidus, • Unstable or painful metatarsal/phalangeal (MTP) joint.

Total Arthroplasty: For a MTP total arthroplasty, a two-piece anatomically designed phalangeal device with a UHMW-PE (ASTM 2759) insert and titanium (ASTM F67) base couples with the metatarsal hemi-arthroplasty device to create a non-constrained total joint replacement. The system is designed for non-cemented (i.e. press-fit) fixation. Indications for use include: • Painful degenerative metatarso-phalangeal joint change, • Hallux rigidus stages 3 and 4, • Hallux valgus and hallux rigidus, • Hallux limitus with painful arthrofibrosis, • Revisions after moderate proximal phalanx resection

Ascension Orthopedics 11101 Metric Blvd Texas - 78758 - USA Phone: 512.836.5001 Fax: 512.836.6933

CE 0086 Ascension Orthopedics, Ltd. Biopark, Broadwater Road Walwyn Garden City Herts, AL7 3AX United Kingdom

Contraindications: Active local or systemic infection: • Destruction of the 1st metatarsal head or 1st proximal phalanx base or poor bone quality which prevents adequate fixation of the implant, • Loss of musculature, neuromuscular compromise, or vascular deficiency in the affected toe.

System Features: • Total and hemi resurfacing implantsfor both sides of the joint in one instrument set: • Total implant components can be mismatched for an anatomical fit, • Cannulated system, • Conical reaming maintains tissue attachments and sesamoid apparatus while allowing for minimal bone resection and pathway for revision, • Dorsal metatarsal cut guide allows for precise cheilectomy of dorsal osteophytes when implanting the metatarsal component.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Movement is a trademark of Integra LifeSciences Corporation or its subsidiaries.

Products mentioned in this document are CE class IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European directive 93/42/EEC on medical devices and its relative, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

37

Forefoot

HALLU®-LOCK MTP Arthrodesis System Implants Reference

Description

HALLU® -Lock C plate 10° 290340S

Hallu®-Lock C plate - right S1

290345S

Hallu®-Lock C plate - right S2

290350S

Hallu®-Lock C plate - right S3

290440S

Hallu®-Lock C plate - left S1

290445S

Hallu®-Lock C plate - left S2

290450S

Hallu®-Lock C plate - left S3

HALLU®-Lock C plate 10°

Surfix® standard screw Dia. 2.7 mm + Lock-screw

HALLU® -Lock S plate 10° 290150S

Hallu®-Lock S plate 10° - right S1

290155S

Hallu®-Lock S plate 10° - right S2

290160S

Hallu®-Lock S plate 10° - right S3

290250S

Hallu®-Lock S plate 10° - left S1

290255S

Hallu®-Lock S plate 10° - left S2

290260S

Hallu®-Lock S plate 10° - left S3

Surfix® standard screw Dia. 3.0 mm + Lock-screw

HALLU®-Lock S plate 10°

SURFIX® SCREWS AND LOCK SCREW DIA 2.7MM

38

285210S

SURFIX® screw and lock screw titanium dia. 2.7mm L.10mm

285212S

SURFIX® screw and lock screw titanium dia. 2.7mm L.12mm

285214S

SURFIX® screw and lock screw titanium dia. 2.7mm L.14mm

285216S

SURFIX® screw and lock screw titanium dia. 2.7mm L.16mm

285218S

SURFIX® screw and lock screw titanium dia. 2.7mm L.18mm

285220S

SURFIX® screw and lock screw titanium dia. 2.7mm L.20mm

285222S

SURFIX® screw and lock screw titanium dia. 2.7mm L.22mm

295222S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.22mm

285224S

SURFIX® screw and lock screw titanium dia. 2.7mm L.24mm

295224S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.24mm

285226S

SURFIX® screw and lock screw titanium dia. 2.7mm L.26mm

295226S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.26mm

185200S

SURFIX® Lock screw titanium for dia. 2.7mm screw

195200S

SURFIX® Alpha Lock screw titanium dia. 2.7mm

Surfix® Alpha variable angle screw Dia. 2.7 mm + Lock-screw

Surfix® Alpha variable angle screw Dia. 3.0 mm + Lock-screw

QWIX® transarticular compressive screw

SURFIX® SCREWS & LOCK SCREW DIA 3.0mm

SURFIX® ALPHA SCREWS & LOCK SCREW DIA 3.0mm

285110S

SURFIX® screw and lock screw titanium dia. 3.0mm L.10mm

295110S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.10mm

285112S

SURFIX® screw and lock screw titanium dia. 3.0mm L.12mm

295112S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.12mm

285114S

SURFIX® screw and lock screw titanium dia. 3.0mm L.14mm

295114S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.14mm

285116S

SURFIX® screw and lock screw titanium dia. 3.0mm L.16mm

295116S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.16mm

285118S

SURFIX® screw and lock screw titanium dia. 3.0mm L.18mm

295118S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.18mm

285120S

SURFIX® screw and lock screw titanium dia. 3.0mm L.20mm

295120S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.20mm

285122S

SURFIX® screw and lock screw titanium dia. 3.0mm L.22mm

295122S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.22mm

285124S

SURFIX® screw and lock screw titanium dia. 3.0mm L.24mm

295124S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.24mm

285126S

SURFIX® screw and lock screw titanium dia. 3.0mm L.26mm

295126S

SURFIX® Alpha screw and lock screw titanium dia. 3.0mm L.26mm

185100S

SURFIX® Lock screw titanium for dia. 3.0mm screw

195100S

SURFIX® Alpha Lock screw titanium dia. 3.0mm

SURFIX® ALPHA SCREWS & LOCK SCREW DIA 2.7mm

QWIX COMPRESSION SCREW DIA 3.0mm

295210S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.10mm

111324S

QWIX® screw dia. 3mm L.24mm

295212S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.12mm

111326S

QWIX® screw dia. 3mm L.26mm

295214S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.14mm

111328S

QWIX® screw dia. 3mm L.28mm

295216S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.16mm

111330S

QWIX® screw dia. 3mm L.30mm

295218S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.18mm

111332S

QWIX® screw dia. 3mm L.32mm

295220S

SURFIX® Alpha screw and lock screw titanium dia. 2.7mm L.20mm

111334S

QWIX® screw dia. 3mm L.34mm

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

Instruments Reference

Description

CONTAINER 299900

Instruments tray for HALLU®-LOCK

Including the following component : 299 901

Base

299 903

Trial implant tray

299 904

K-wire tray

996 200

Lid

299 070

Hallu® Lock C plate bender left

299 080

Hallu® Lock C plate bender right

219 027

Drilling guide dia. 2.0mm

299 150

Hallu® Lock S trial implant right S1

219 127

Torx T7 screwdriver

299 155

Hallu® Lock S trial implant right S2

219 227

Torx T7 screwdriver blade - AO tip

299 160

Hallu® Lock S trial implant right S3

219 627

Drilling guide Surfix® dia 2.0mm

299 250

Hallu® Lock S trial implant left S1

299 020

Depth gauge

299 255

Hallu® Lock S trial implant left S2

129 710

Quick Coupling

299 260

Hallu® Lock S trial implant left S3

997 100

Quick coupling attachment system large AO

299 340

Hallu® Lock C trial implant right S1

129 714

Metatarsal reamer dia. 14mm

299 345

Hallu® Lock C trial implant right S2

129 716

Metatarsal reamer dia. 16mm

299 350

Hallu® Lock C trial implant right S3

129 718

Metatarsal reamer dia. 18mm

299 440

Hallu® Lock C trial implant left S1

129 720

Metatarsal reamer dia. 20mm

299 445

Hallu® Lock C trial implant left S2

129 722

Metatarsal reamer dia. 22mm

299 450

Hallu® Lock C trial implant left S3

129 724

Phalangeal reamer dia. 14mm

119 133

Handle with AO quick attachment dia. 3.0mm

129 726

Phalangeal reamer dia. 16mm

119 135

Screwdriver axis dia. 3,0mm

129 728

Phalangeal reamer dia. 18mm

159 027

AO "2 in 1" cannulated drill dia. 2.2/3.0mm L.12mm

129 730

Phalangeal reamer dia. 20mm

115 070

K-wire dia. 1.0mm L.70mm - 1 sharp

129 752

Phalangeal reamer dia. 22mm

115 100

K-wire dia. 1.0mm L.100mm - 2 sharps

299 010

Trial implant holder

115 116

K-wire dia. 1.6mm L.150mm - 1 sharp

299 005

Drill dia 2.0mm

299 050

Drill dia 2.0mm - AO tip

forefoot

INSTRUMENTATION

: Available in spare part for replacement

HALLU®-LOCK MTP Arthrodesis System Indications: For use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint, including cases of : -Hallux rigidus -Severe Hallux valgus (IM angle >20° and HV angle > 40°) -Deformity from rheumatoid arthritis -Failed previous surgical procedure -Traumatic arthritis -Neuromuscular instability. HALLU® Lock Newdeal® plates must be fixed with the SURFIX® fixed angle locking system and with the SURFIX® -Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws). Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France +33(0)4 37 47 51 51 fax: +33(0)4 37 47 51 52

Warnings: Serious post-operative complications may occur from use of the implant in a patient who: -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials; -Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. HALLU is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

CE 0120

Products mentioned in this document are CE class I, IIa, IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

39

Forefoot

HALLU®-FIX MTP Arthrodesis System Implants Reference

Description

117340(S)

Hallu®-C plate size 1 - right

117345(S)

Hallu®-C plate size 2 - right

117350(S)

Hallu®-C plate size 3 - right

117440(S)

Hallu®-C plate size 1 - left

117445(S)

Hallu®-C plate size 2 - left

117450(S)

Hallu®-C plate size 3 - left

117150(S)

Hallu®-S plate size 1 - right

117155(S)

Hallu®-S plate size 2 - right

117160(S)

Hallu®-S plate size 3 - right

117250(S)

Hallu®-S plate size 1 - left

117255(S)

Hallu®-S plate size 2 - left

117260(S)

Hallu®-S plate size 3 - left

117010(S)

Snap off screw dia. 2.7mm L.10mm

117012(S)

Snap off screw dia. 2.7mm L.12mm

117014(S)

Snap off screw dia. 2.7mm L.14mm

117016(S)

Snap off screw dia. 2.7mm L.16mm

117018(S)

Snap off screw dia. 2.7mm L.18mm

117020(S)

Snap off screw dia. 2.7mm L.20mm

117022(S)

Snap off screw dia. 2.7mm L.22mm

117024(S)

Snap off screw dia. 2.7mm L.24mm

117026(S)

Snap off screw dia. 2.7mm L.26mm

117028(S)

Snap off screw dia. 2.7mm L.28mm

117030(S)

Snap off screw dia. 2.7mm L.30mm

117032(S)

Snap off screw dia. 2.7mm L.32mm

117034(S)

Snap off screw dia. 2.7mm L.34mm

117110(S)

Snap off screw dia. 3mm L.10mm

117112(S)

Snap off screw dia. 3mm L.12mm

117114(S)

Snap off screw dia. 3mm L.14mm

117116(S)

Snap off screw dia. 3mm L.16mm

117118(S)

Snap off screw dia. 3mm L.18mm

(S) means available in sterile and non sterile.

40

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

Forefoot

Instruments Reference

Description K-WIRES

CONTAINER 129930

Instruments tray for HALLU®-FIX

Including the following component : 129931

Container base

129932

Hallu®-C plates tray

129933

Hallu®-S plates tray

996200

Lid

129936

Screws rack

115100

K-wire dia. 1.0mm L.100mm - 2 sharps

115216

K-wire dia. 1.6mm L.150mm - 2 sharps

129 731

Plate bender left

129732

Plate bender right

129 733

Snap-Off screwdriver

129 734

Drilling guide dia. 1.9mm

129 735

Screwdriver tip

129 736

Measurer

129 710

Quick Coupling

129 714

Metatarsal reamer dia. 14mm

129716

Metatarsal reamer dia. 16mm

129718

Metatarsal reamer dia. 18mm

129720

Metatarsal reamer dia. 20mm

129722

Metatarsal reamer dia. 22mm

129 724

Phalangeal reamer dia. 14mm

129726

Phalangeal reamer dia. 16mm

129728

Phalangeal reamer dia. 18mm

129 730

Phalangeal reamer dia. 20mm

129 752

Phalangeal reamer dia. 22mm

119618

Drill dia. 1.9mm L.100mm

forefoot

INSTRUMENTATION

HALLU®-FIX MTP Arthrodesis System Indications: For use in fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint, including cases of : -Hallux rigidus -Severe Hallux Hallux valgus (IM angle >20° and HV angle > 40°) -Deformity from rheumatoid arthritis -Failed previous surgical procedure -Traumatic arthritis -Neuromuscular instability. The HALLU®-Fix Plates have to be fixed with the SNAP-OFF® screws. Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -Local or systemic acute or chronic inflammation; -Active infection or inflammation; -Suspected or documented metal allergy or intolerance. Warnings: Serious post-operative complications may occur from use of the implant in a patient who: -Lacks good general physical condition; -Has severe osteoporosis; -Demonstrates physiologic or anatomic anomalies; -Has immunological responses, sensitization, or hypersensitivity to foreign materials; -Systemic or metabolic disorders.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. HALLU is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Newdeal SAS Immeuble Sequoia 2 97 Allee Alexandre Borodine Parc Technologique de la porte des Alpes 69800 Saint Priest - France Phone: +33(0)4 37 4751 51 Fax: +33(0)4 37 47 51 52

CE 0120

Products mentioned in this document are CE class I, IIa, IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

41

Forefoot

HALLU®-REAM metatarsal reamers; phalangeal reamers Implant Reference

Description

CONTAINER 129935

Container

Including the following component : 129938

Basis

996100

Lid standard

INSTRUMENTATION 129710

Quick Coupling

129714

Metatarsal reamer dia. 14mm

129716

Metatarsal reamer dia. 16mm

129718

Metatarsal reamer dia. 18mm

129720

Metatarsal reamer dia. 20mm

129722

Metatarsal reamer dia. 22mm

129724

Phalangeal reamer dia. 14mm

129726

Phalangeal reamer dia. 16mm

129728

Phalangeal reamer dia. 18mm

129730

Phalangeal reamer dia. 20mm

129752

Phalangeal reamer dia. 22mm

115216

K-wire dia. 1.6mm L.150mm - 2 sharps

HALLU®-REAM Set Indications/contraindications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Newdeal and Surfix® products ranges. None of the instruments should be implanted. Only medical professionals who are thoroughly familiar with the instruments function, application, and use should use them in surgery. Only a surgeon qualified to perform the orthopedic surgery required by the particular patient should use the surgical instruments. Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff. These devices do not contain phthalates unless this is indicated on the label.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Hallu is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

Products mentioned in this document are CE class I, IIa and IIb devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

42

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

CE 0120

Forefoot

Removal instruments for Hallu®-Fix MTP arthrodesis system, Hallu®-Lock artrhodesis system KWires Reference

Description

115070

K-wire dia. 1.0mm L.70mm - 1 sharp

115100

K-wire dia. 1.0mm L.100mm - 2 sharps

Instrumentation Description

219227

Torx T7 screwdriver blade - AO tip

219127

Torx T7 screwdriver

229002

Cannulated hexagonal screwdriver 2mm

129733

Snap-Off screwdriver

forefoot

Reference

Removal instruments for Hallu®-Fix MTP arthrodesis system, Hallu®-Lock artrhodesis system Indications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Newdeal and Surfix® products ranges. None of the instruments should be implanted. Only medical professionals who are thoroughly familiar with the instruments function, application, and use should use them in surgery. Only a surgeon qualified to perform the orthopedic surgery required by the particular patient should use the surgical instruments. Improper maintenance, handling, or poor cleaning procedures can render the instrument unsuitable for its intended purpose, or even dangerous to the patient or surgical staff. These devices do not contain phtalates unless this is indicated on the label.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. HALLU is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

CE 0120

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Products mentioned in this document are CE class I, IIa and IIb. Please contact Integra customer service should you need any additional information on devices classification.

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

43

Forefoot

DPR System Minimal Invasive Foot Surgery Instrument Reference

Description

CONTAINER 278900

Instruments tray for DPR SYSTEM

Including the following component: 278901

Basis minimal invasive

996100

Lid standard

278902

Mat

119909

4 Blue silicone wedges

INSTRUMENTATION 278121

Curette medium - Down

278122

Curette medium - Up

278123

Curette large - Down

278124

Curette large - Up

278109

Sleeve protection dia.4.1mm

278110

Sleeve protection dia.3.1mm

278100

Sleeve protection cap

DPR BURRS 278002S

Burr straight dia.2.0mm L.15mm

278007S

Burr conical dia.3.1mm L.12mm

278005S

Burr straight dia.2.0mm L.10mm

278008S

Burr conical dia.4.1mm L.12mm

278009S

Burr cylindrical dia.4.1mm L.15mm

278010S

Burr cylindrical dia.3.1mm L.15mm

OR 278002X

Batch of 5 burrs straight dia.2.0mm L.15mm

278007X

Batch of 5 burrs conical dia.3.1mm L.12mm

278005X

Batch of 5 burrs straight dia.2.0mm L.10mm

278008X

Batch of 5 burrs conical dia.4.1mm L.12mm

278009X

Batch of 5 burrs cylindrical dia.4.1mm L.15mm

278010X

Batch of 5 burrs cylindrical dia.3.1mm L.15mm

DPR System Minimal Invasive Foot Surgery Indications: The DPR system is surgery instruments intended for minimal invasive foot surgery including cases of: • Hallux valgus treatment and Hallux Rigidus treatment • Haglund Syndrom treatment • Mid & Hind foot arthritis treatment. • Hallus valgus with DMMA deformity treatment • Hammer toe treatment • Claw toe treatment • 5th ray bunionectomy Contraindications: Not applicable.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Newdeal SAS Immeuble Séquoia 2 - 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest - France Phone: +33 (0) 4 37 47 51 51 Fax: +33 (0) 4 37 47 51 52

Products mentioned in this document are CE class I, IIa devices. Please contact Integra customer service should you need any additional information on devices classification.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Last revision date: 04/2018.

44

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

CE 0120

Forefoot

Post-Operative Shoes Flat Post Operative Shoe Reference

Description

999001

Small post-op shoe plate sole model

999002

Medium post-op shoe plate sole model

999003

Large post-op shoe plate sole model

999004

X-large post-op shoe plate sole model

Wedged Hell Post Operative Shoe Description

999100

Small post-op shoe wedge healing model

999101

Medium post-op shoe wedge healing model

999102

Large post-op shoe wedge healing model

forefoot

Reference

Post-Operative Shoes Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

• Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

• Warning: Applicable laws restrict these products to sale by or on the order of a physician.

• Consult product labels for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

• Products mentioned in this document are CE class I devices. Please contact Integra customer service should you need any additional information on devices classification.

All the medical devices mentioned on this document are CE marked according to European council directive 93/42/EEC on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

Deltai Medical & health Articles (Suzhou) Co. Ltd 60, Feihu Road, LuduTaican, Suzhou Jiangsu, 215412 China Phone: +86-512-53458488 Fax: +86-512-53458119 Shangaï International Trading Corp. GmbH (Hamburg) Eiffestrasse 80, 20537 Hamburg, Germany

Last revision date: 04/2018.

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

45

Forefoot

46

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

forefoot

Forefoot

DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST AND AFRICA ONLY

47

Integra® Forefoot Product Catalogue For more information or to place an order, please contact: Sales & Marketing EMEA Integra LifeSciences Services (France) SAS Immeuble Séquoia 2 ▪ 97 allée Alexandre Borodine Parc technologique de la Porte des Alpes 69800 Saint Priest ▪ FRANCE +33 (0)4 37 47 59 00 phone ▪ +33 (0)4 37 47 59 99 fax integralife.eu

Customer Services

International: +33 (0) 4 37 47 59 50 ▪ +33 (0) 4 37 47 59 25 (fax) ▪ csemea@integralife.com France: +33 (0) 4 37 47 59 10 ▪ +33 (0) 4 37 47 59 29 (fax) ▪ custsvcfrance@integralife.com Benelux: +32 (0) 2 257 41 30 ▪ +32 (0) 2 253 24 66 (fax) ▪ custsvcbenelux@integralife.com United Kingdom: +44 (0) 1264 312 725 ▪ +44 (0) 1264 312 821 (fax) ▪ custsvcsuk@integralife.com Switzerland: +41 (0) 2 27 21 23 00 ▪ +41 (0)2 27 21 23 99 (fax) ▪ custsvcsuisse@integralife.com

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region.

▪ Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.

▪ Warning: Applicable laws restrict these products to sale by or on the order of a physician.

▪ Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

PyroDisk, NuGrip, PyroHemiSphere, PuroSphere, Endorelease, Safeguard, Universal 2, First Choice, Spider, Mini-Spider, Katalyst, Titan, are trademarks of Integra LifeSciences Corporation in the United State and / or other countries.

Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United Sates and/or other countries. ©2018 Integra LifeSciences Corporation. All rights reserved. Last revision date: 04/2018. 0952790-1-EN DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY.