CATALOG MEDIO SI RETROPICIOR INTEGRA ( USA) by ENLIFE SOLUTIONS

IntegraÂŽ Mid and HindFoot Product Catalogue

Table of content

Screws fixations QWIX® Fixation screw, dia. 4.3mm �������������������������������������������������������������������������������������������������������������������������������������������������7 LARGE QWIX ® Fixation and Positioning Screws ������������������������������������������������������������������������������������������������������������������������� 8 QWIX® Removal Instruments ��������������������������������������������������������������������������������������������������������������������������������������������������������10 ICOS® Ideal Compression Screw ����������������������������������������������������������������������������������������������������������������������������������������������������11 ICOS® Removal Set ��������������������������������������������������������������������������������������������������������������������������������������������������������������������������14 Flat foot solutions MBA™ Titanium Subtalar Implant ������������������������������������������������������������������������������������������������������������������������������������������������18 Plating solutions Lisfranc Plates ADVANSYS® DLP - ADVANSYS® MLP ������������������������������������������������������������������������������������������������������������������������������������������� 22 UNI-CP™ Compression Plate ������������������������������������������������������������������������������������������������������������������������������������������������������� 24 Total Foot system II Total Foot System 2 Rearfoot �������������������������������������������������������������������������������������������������������������������������������������������������������� 28 Ankle solutions Ankle arthrodesis ADVANSYS® TTC Fusion Plate ������������������������������������������������������������������������������������������������������������������������������������������������������� 32 PANTA® / PANTA® XL Arthrodesis Nail ���������������������������������������������������������������������������������������������������������������������������������������� 34 PANTA® Removal set �����������������������������������������������������������������������������������������������������������������������������������������������������������������������37 TIBIAXYS® Ankle Arthrodesis Plating System ����������������������������������������������������������������������������������������������������������������������������� 38 Distal osteotomy TIBIAXYS® Distal Tibia and Fibula Osteotomy Plating System ������������������������������������������������������������������������������������������������40 Total Ankle Replacement Specific catalogue on request Sport medicine Achillon® Minimal Invasive Achilles Tendon Suture System ���������������������������������������������������������������������������������������������������� 44 Instruments Removal Instruments for Advansys®, Tibiaxys® and Uni-CP™ ������������������������������������������������������������������������������������������������ 48 Integra Distraction Forceps ����������������������������������������������������������������������������������������������������������������������������������������������������������� 49

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

3

4

IntegraÂŽ Mid and HindFoot Screws fixations

Mid & HindFoot

Mid & HindFoot

QWIX® Fixation Screw, dia. 4.3mm Implant Reference

Description

111422S

QWIX® screw dia. 4.3mm L.22mm

111424S

QWIX® screw dia. 4.3mm L.24mm

111426S

QWIX® screw dia. 4.3mm L.26mm

111428S

QWIX® screw dia. 4.3mm L.28mm

111430S

QWIX® screw dia. 4.3mm L.30mm

111432S

QWIX® screw dia. 4.3mm L.32mm

111434S

QWIX® screw dia. 4.3mm L.34mm

111436S

QWIX® screw dia. 4.3mm L.36mm

111438S

QWIX® screw dia. 4.3mm L.38mm

111440S

QWIX® screw dia. 4.3mm L.40mm

111445S

QWIX® screw dia. 4.3mm L.45mm

111450S

QWIX® screw dia. 4.3mm L.50mm

111455S

QWIX® screw dia. 4.3mm L.55mm

111460S

QWIX® screw dia. 4.3mm L.60mm

Instrument Reference

Description

CONTAINER 119935

Instruments tray for QWIX® Ø 4,3mm

Including the following components: 119936

Dia. 4,3mm base instruments set

996400

Lid 22/17 Standard

119937

Cylinder for screw dia. 4,3mm

119938

Silicone carpet

119138

Handle with AO quick attachment dia. 4,3mm

119104

Screwdriver axis for dia. 4,3mm screw

119139

Short drill dia. 2.6mm for dia. 4,3mm screw

115116

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

119516

4,0mm long cannulated drill

: Available in spare part for replacement

QWIX® Fixation Screw, dia. 4.3mm 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 (including 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. Qwix is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries.

midfoot

INSTRUMENTATION

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

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 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: 02/2018.

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

7

Mid & HindFoot

LARGE QWIX® Fixation and Positioning Screws, dia. 5.5mm / 7.5mm Implant Reference

Implant Description

Reference

POSITIONING SCREW

8

Description

FIXATION SCREW

121530S

Positioning screw dia. 5.5mm L.30mm

111530S

Fixation screw dia. 5.5mm L.30mm

121535S

Positioning screw dia. 5.5mm L.35mm

111535S

Fixation screw dia. 5.5mm L.35mm

121540S

Positioning screw dia. 5.5mm L.40mm

111540S

Fixation screw dia. 5.5mm L.40mm

121545S

Positioning screw dia. 5.5mm L.45mm

111545S

Fixation screw dia. 5.5mm L.45mm

121550S

Positioning screw dia. 5.5mm L.50mm

111550S

Fixation screw dia. 5.5mm L.50mm

121555S

Positioning screw dia. 5.5mm L.55mm

111555S

Fixation screw dia. 5.5mm L.55mm

121560S

Positioning screw dia. 5.5mm L.60mm

111560S

Fixation screw dia. 5.5mm L.60mm

121565S

Positioning screw dia. 5.5mm L.65mm

111565S

Fixation screw dia. 5.5mm L.65mm

121570S

Positioning screw dia. 5.5mm L.70mm

111570S

Fixation screw dia. 5.5mm L.70mm

121575S

Positioning screw dia. 5.5mm L.75mm

111575S

Fixation screw dia. 5.5mm L.75mm

121580S

Positioning screw dia. 5.5mm L.80mm

111580S

Fixation screw dia. 5.5mm L.80mm

121740S

Positioning screw dia. 7.5mm L.40mm

111740S

Fixation screw dia. 7.5mm L.40mm

121745S

Positioning screw dia. 7.5mm L.45mm

111745S

Fixation screw dia. 7.5mm L.45mm

121750S

Positioning screw dia. 7.5mm L.50mm

111750S

Fixation screw dia. 7.5mm L.50mm

121755S

Positioning screw dia. 7.5mm L.55mm

111755S

Fixation screw dia. 7.5mm L.55mm

121760S

Positioning screw dia. 7.5mm L.60mm

111760S

Fixation screw dia. 7.5mm L.60mm

121765S

Positioning screw dia. 7.5mm L.65mm

111765S

Fixation screw dia. 7.5mm L.65mm

121770S

Positioning screw dia. 7.5mm L.70mm

111770S

Fixation screw dia. 7.5mm L.70mm

121775S

Positioning screw dia. 7.5mm L.75mm

111775S

Fixation screw dia. 7.5mm L.75mm

121780S

Positioning screw dia. 7.5mm L.80mm

111780S

Fixation screw dia. 7.5mm L.80mm

121785S

Positioning screw dia. 7.5mm L.85mm

111785S

Fixation screw dia. 7.5mm L.85mm

121790S

Positioning screw dia. 7.5mm L.90mm

111790S

Fixation screw dia. 7.5mm L.90mm

121795S

Positioning screw dia. 7.5mm L.95mm

111795S

Fixation screw dia. 7.5mm L.95mm

121800S

Positioning screw dia. 7.5mm L.100mm

111800S

Fixation screw dia. 7.5mm L.100mm

121805S

Positioning screw dia. 7.5mm L.105mm

111805S

Fixation screw dia. 7.5mm L.105mm

121810S

Positioning screw dia. 7.5mm L.110mm

111810S

Fixation screw dia. 7.5mm L.110mm

121815S

Positioning screw dia. 7.5mm L.115mm

111815S

Fixation screw dia. 7.5mm L.115mm

121820S

Positioning screw dia. 7.5mm L.120mm

111820S

Fixation screw dia. 7.5mm L.120mm

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

Mid & HindFoot

Instrument Reference

Description

CONTAINER 121950

Instruments tray for LARGE QWIX®

Including the following components: 121951

Instrument tray base

996200

Lid

119170

Cylinder

119909

4 Blues silicone wedges

INSTRUMENTATION 119150

Measurer

119151

Protection sleeve 1 for 5.5mm screws

119152

Protection sleeve 2 for 5.5mm screws

119153

Protection sleeve 3 for 5.5mm screws

119154

Cannulated drill dia. 4.2mm L.140mm

119155

Cannulated and shouldered drill for 5.5mm screws

119156

Screwdriver tip for 5.5mm screws

119157

Quick coupling handle

119171

Protection sleeve 1 for 7.5mm screws

119172

Protection sleeve 2 for 7.5mm screws

119173

Protection sleeve 3 for 7.5mm screws

119174

Cannulated drill dia. 5,5mm L.180mm

119175

Cannulated and shouldered drill for 7.5mm screws

119176

Screwdriver tip for 7.5mm screws

119177

Quick coupling T-handle

K-WIRE 115516

K-wire dia. 1.6mm L.200mm - 1 sharp

529061

K-wire dia. 2.5mm L.250mm - 1 sharp

midfoot

: Available in spare part for replacement

LARGE QWIX® Fixation and Positioning Screws, dia. 5.5mm / 7.5mm 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 (including 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. Qwix 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

CE 0120

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 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: 02/2018.

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

9

Mid & HindFoot

Removal instruments for QWIX® Fixation Screw, dia. 4.3mm and Large QWIX® Fixation and Positioning Screws, dia. 5.5mm / 7.5mm Instruments Reference

Description

119104

Screwdriver tip for 4,3mm screw

119156

Screwdriver tip for 5.5mm screws

119176

Screwdriver tip for 7.5mm screws

119177

Quick coupling T-handle

K-Wires Reference

Description

115516

K-wire dia. 1.6mm L.200mm - 1 sharp

529061

K-wire dia. 2.5mm L.250mm - 1 sharp

115116

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

Removal instruments for QWIX® Fixation Screw, dia. 4.3mm and Large QWIX® Fixation and Positioning Screws, dia. 5.5mm / 7.5mm Indications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Neweal 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 sugery. Only a sugeon 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.

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: 02/2018.

10

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

CE 0120

Mid & HindFoot

I.CO.S.® Ideal Compression Screw dia. 4.0mm Implant Reference

Instrument Description

Reference

SCREW

Description

CONTAINER

105426

I.CO.S® screw dia. 4.0mm L.26mm

119974

105428

I.CO.S® screw dia. 4.0mm L.28mm

Including the following components:

Instruments and implants tray for ICOS® Ø4 mm

105430

I.CO.S® screw dia. 4.0mm L.30mm

119951

4,0mm screws tray

105432

I.CO.S® screw dia. 4.0mm L.32mm

119956

Base for sterilization container 4.0mm

105434

I.CO.S® screw dia. 4.0mm L.34mm

996200

Lid

105436

I.CO.S® screw dia. 4.0mm L.36mm

119909

4 Blue silicone wedges

105438

I.CO.S® screw dia. 4.0mm L.38mm

119949

Inside container lid

105440

I.CO.S® screw dia. 4.0mm L.40mm

INSTRUMENTATION

105445

I.CO.S® screw dia. 4.0mm L.45mm

119510

ICOS® measurer

105450

I.CO.S® screw dia. 4.0mm L.50mm

119525

4,0mm tap

105455

I.CO.S® screw dia. 4.0mm L.55mm

119506

4,0mm drilling guide

105460

I.CO.S® screw dia. 4.0mm L.60mm

119501

4,0mm protecting sleeve

119516

4,0mm long cannulated drill

119522

4,0mm short cannulated drill

119531

4,0mm screwdriver

119532

4,0mm screwdriver tip

119536

4,0mm external screwdriver

129710

Quick Coupling

115116

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

midfoot

: Available in spare part for replacement

I.CO.S.® Ideal Compression Screw dia. 4.0mm Indications: The I.CO.S® screws are indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of bone fragments, in long bones or small bones fractures; Fractures management in the foot or hand; Arthrodesis in hand, foot or ankle surgery; Mono or Bi-cortical osteotomies in the foot or hand or in long bones; Treatment of inferior tibio fibular diastasis; 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.

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

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. I.CO.S. 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 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: 02/2018.

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

11

Mid & HindFoot

I.CO.S.® Ideal Compression Screw dia 6.5mm Implant Reference

Description

SCREWS

12

105640

I.CO.S® screw dia. 6.5mm L.40mm

105645

I.CO.S® screw dia. 6.5mm L.45mm

105650

I.CO.S® screw dia. 6.5mm L.50mm

105655

I.CO.S® screw dia. 6.5mm L.55mm

105660

I.CO.S® screw dia. 6.5mm L.60mm

105665

I.CO.S® screw dia. 6.5mm L.65mm

105670

I.CO.S® screw dia. 6.5mm L.70mm

105675

I.CO.S® screw dia. 6.5mm L.75mm

105680

I.CO.S® screw dia. 6.5mm L.80mm

105685

I.CO.S® screw dia. 6.5mm L.85mm

105690

I.CO.S® screw dia. 6.5mm L.90mm

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

Mid & HindFoot

Instrument Reference

Description

CONTAINER 119976

Instruments and implants tray for ICOS® Ø 6,5mm

Including the following components: 119953

6,5mm screws tray

119958

Base for sterilization container 6.5mm

996200

Lid

119949

Inside container lid

119909

4 Blue silicone wedges

INSTRUMENTATION 119510

ICOS® measurer

119555

6,5mm tap

119541

6,5mm drilling guide

119551

6,5mm internal protecting sleeve

119552

6,5mm external protecting sleeve

119571

6,5mm long cannulated drill

119546

6,5mm short cannulated drill

119561

6,5mm screwdriver

119562

6,5mm screwdriver tip

119566

6,5mm external screwdriver

129710

Quick Coupling

115225

Graduated K-wire dia. 2.5mm L.200mm - 1 sharp

midfoot

: Available in spare part for replacement

I.CO.S. ® Ideal Compression Screw dia 6.5mm Indications: The I.CO.S® screws are indicated for fixation of bone fractures or for bone reconstruction. Examples include: -Fixation of bone fragments, in long bones or small bones fractures.

-Fractures management in the foot or hand -Arthrodesis in hand, foot or ankle surgery -Mono or Bi-cortical osteotomies in the foot or hand or in long bones -Treatment of inferior tibio fibular diastasis 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.

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

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. I.CO.S. 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, Im 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: 02/2018.

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

13

Mid & HindFoot

I.CO.S® Removal Set Instrumentation Reference

Description

CONTAINER 119975

Instruments tray for I.CO.S® REMOVAL

Including the following components: 119955

Base for ablation set

119977

Cylinder for ablation kit

996100

Lid standard

INSTRUMENTATION 4.0 115116

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

119531

4,0mm screwdriver

119580

4,0mm trephine

119582

4,0mm extractor

INSTRUMENTATION 6.5 115225

Graduated K-wire dia. 2.5mm L.200mm - 1 sharp

119561

6,5mm screwdriver

119590

6,5mm trephine

119592

6,5mm extractor : Available in spare part for replacement

I.CO.S® Removal Set These instruments are intended for use in surgery, and should be used only for the introduction of associated Newdeal 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.

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. I.CO.S. 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 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: 02/2018.

14

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

midfoot

Mid & HindFoot

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

15

16

IntegraÂŽ Mid and HindFoot Flat foot solutions

Mid & HindFoot

MBA™ Titanium Subtalar Implant Implant Reference

Description

50106

MBA, 6mm

50108

MBA, 8mm

50109

MBA, 9mm

50110

MBA, 10mm

50112

MBA, 12mm

Instrumentation Reference

Description

050016

GUIDE PIN INSERT HOLDER

050206

TRIAL, 6MM

050208

TRIAL, 8MM

050209

TRIAL, 9MM

050210

TRIAL, 10MM

050212

TRIAL, 12MM

051002

PROBE

051006

6MM SIZER

051008

8MM SIZER

051009

9MM SIZER

051010

10MM SIZER

051012

12MM SIZER

051020

INSERTION DEVICE

055001

STERILIZATION TRAY

050017

GUIDE PIN 2MM

MBA™ Titanium Subtalar Implant Indications: The Subtalar MBA System is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.- Severely pronated foot - Walking intemperance - Calcaneal stance position greater than 5° - Manually correctable deformities - Mid-tarsal breech (arch pain) -Forefoot varus greater than 10° Contraindications: The Subtalar MBA implant is contraindicated for use in patients with the following conditions: - Active local infection. (Any evidence of infection) - Metal sensitivity or allergic reaction to foreign bodies - Poor or insufficient bone stock - The presence of any clinical or functional abnormalities that would preclude the potential of achieving a good result for the patient - Other conditions that may place the patient at risk (Physiologically) MBA, Subtalar MBA, Integra and the Integra logo are trademarks of Integra LifeSciences Corporation. Klenzyme, Enzol and Renuklenz are trademarks or registered trademarks of their respective owners.

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.

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

• 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 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: 01/2018.

18

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

Integra LifeSciences Corp 4900 Charlemar Drive, Building A Cincinnati Ohio 45227 USA

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

midfoot

Mid & HindFoot

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

19

20

IntegraÂŽ Mid and HindFoot Plating solutions

Mid & HindFoot

ADVANSYS® DLP - ADVANSYS® MLP Implant Reference

ADVANSYS® Medial Lisfranc Plate

181021S

Small right dorsal plate

181041S

Small right medial plate

181022S

Medium right dorsal plate

181042S

Large right medial plate

181023S

Large right dorsal plate

181051S

Small left medial plate

181031S

Small left dorsal plate

181052S

Large left medial plate

181032S

Medium left dorsal plate

181033S

Large left dorsal plate

TITANIUM SCREW

STAINLESS STEEL SCREW

285310S

SURFIX® screw and lock screw titanium dia. 3.5mm L.10mm

286310S

screw and locking screw - stainless steel dia. 3.5mm L.10mm

285312S

SURFIX® screw and lock screw titanium dia. 3.5mm L.12mm

286312S

screw and locking screw - stainless steel dia. 3.5mm L.12mm

285314S

SURFIX® screw and lock screw titanium dia. 3.5mm L.14mm

286314S

screw and locking screw - stainless steel dia. 3.5mm L.14mm

285316S

SURFIX® screw and lock screw titanium dia. 3.5mm L.16mm

286316S

screw and locking screw - stainless steel dia. 3.5mm L.16mm

285318S

SURFIX® screw and lock screw titanium dia. 3.5mm L.18mm

286318S

screw and locking screw - stainless steel dia. 3.5mm L.18mm

285320S

SURFIX® screw and lock screw titanium dia. 3.5mm L.20mm

286320S

screw and locking screw - stainless steel dia. 3.5mm L.20mm

285322S

SURFIX® screw and lock screw titanium dia. 3.5mm L.22mm

286322S

screw and locking screw - stainless steel dia. 3.5mm L.22mm

285324S

SURFIX® screw and lock screw titanium dia. 3.5mm L.24mm

286324S

screw and locking screw - stainless steel dia. 3.5mm L.24mm

285326S

SURFIX® screw and lock screw titanium dia. 3.5mm L.26mm

286326S

screw and locking screw - stainless steel dia. 3.5mm L.26mm

285328S

SURFIX® screw and lock screw titanium dia. 3.5mm L.28mm

286328S

screw and locking screw - stainless steel dia. 3.5mm L.28mm

285330S

SURFIX® screw and lock screw titanium dia. 3.5mm L.30mm

286330S

screw and locking screw - stainless steel dia. 3.5mm L.30mm

285332S

SURFIX® screw and lock screw titanium dia. 3.5mm L.32mm

286332S

screw and locking screw - stainless steel dia. 3.5mm L.32mm

285334S

SURFIX® screw and lock screw titanium dia. 3.5mm L.34mm

286334S

screw and locking screw - stainless steel dia. 3.5mm L.34mm

286336S

screw and locking screw - stainless steel dia. 3.5mm L.36mm

286338S

screw and locking screw - stainless steel dia. 3.5mm L.38mm

286340S

screw and locking screw - stainless steel dia. 3.5mm L.40mm

186300S

Stainless steel locking screw for dia. 3.5mm screw

185300S

22

Description

ADVANSYS® Dorsal Lisfranc Plate

SURFIX® Lock screw titanium for dia. 3.5mm screw

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

Mid & HindFoot

Instrument Reference

Description

CONTAINER 169102

Instruments tray for ADVANSYS® MLP / DLP

Including the following components : 169112

Basis

996200

Lid

169106

Cylinder

169107

Trial implants module

119909

4 Blue silicone wedges

INSTRUMENTATION 219835

Hexagonal screwdriver for 3.5mm screw

219435

AO hexagonal screwdriver 2mm

219635

Drilling guide for 3.5mm screw

219535

AO drill dia. 2.7mm L.125mm

219735

Plate bender 3.5mm

219335

Depth gauge for 3.5 mm screw

169021

Trial plate right small size-dorsal

169022

Trial plate right medium size-dorsal

169023

Trial plate right large size-dorsal

169031

Trial plate left small size-dorsal

169032

Trial plate left medium size-dorsal

169033

Trial plate left large size-dorsal

169041

Trial plate right small size-medial

169042

Trial plate right large size-medial

169051

Trial plate left small size-medial

169052

Trial plate left large size-medial

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

: Available in spare part for replacement

midfoot

115100

ADVANSYS® Lisfranc Plate Indications: Advansys® - DLP (Dorsal Lisfranc Plate) indications: For fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints (Lisfranc joints). The Advansys® DLP Plates have to be fixed with the Surfix® fixed angle screws and lock screws diam. 3.5 mm. • Advansys® - (MLP Medial Lisfranc Plate) indications: For bone fixation such as: -Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, -Lisfranc arthrodesis, -Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

The Advansys® MLP Plates have to be fixed with the Surfix® fixed angle screws and lock screws diam. 3.5 mm.

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. Advansys 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

CE 0120

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: 02/2018.

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

23

Mid & HindFoot

UNI-CP™ Compression plate Implant Reference

Description

PLATES

24

330021S

U shaped compression plate S1

330023S

U shaped compression plate S2

330025S

U shaped compression plate S3

330030S

4 holes compression plate "T" shaped

330217S

2 holes compression plate interaxis 17mm

330220S

2 holes compression plate interaxis 20mm

330225S

2 holes compression plate interaxis 25mm

330230S

2 holes compression plate interaxis 30mm

330420S

4 holes compression plate interaxis 20mm

330425S

4 holes compression plate interaxis 25mm

330430S

4 holes compression plate interaxis 30mm

TITANIUM SCREW

STAINLESS STEEL SCREW

285312S

SURFIX® screw and lock screw titanium dia. 3.5mm L.12mm

286310S

screw and locking screw - stainless steel dia. 3.5mm L.10mm

285314S

SURFIX® screw and lock screw titanium dia. 3.5mm L.14mm

286312S

screw and locking screw - stainless steel dia. 3.5mm L.12mm

285316S

SURFIX® screw and lock screw titanium dia. 3.5mm L.16mm

286314S

screw and locking screw - stainless steel dia. 3.5mm L.14mm

285318S

SURFIX® screw and lock screw titanium dia. 3.5mm L.18mm

286316S

screw and locking screw - stainless steel dia. 3.5mm L.16mm

285320S

SURFIX® screw and lock screw titanium dia. 3.5mm L.20mm

286318S

screw and locking screw - stainless steel dia. 3.5mm L.18mm

285322S

SURFIX® screw and lock screw titanium dia. 3.5mm L.22mm

286320S

screw and locking screw - stainless steel dia. 3.5mm L.20mm

285324S

SURFIX® screw and lock screw titanium dia. 3.5mm L.24mm

286322S

screw and locking screw - stainless steel dia. 3.5mm L.22mm

285326S

SURFIX® screw and lock screw titanium dia. 3.5mm L.26mm

286324S

screw and locking screw - stainless steel dia. 3.5mm L.24mm

285328S

SURFIX® screw and lock screw titanium dia. 3.5mm L.28mm

286326S

screw and locking screw - stainless steel dia. 3.5mm L.26mm

285330S

SURFIX® screw and lock screw titanium dia. 3.5mm L.30mm

286328S

screw and locking screw - stainless steel dia. 3.5mm L.28mm

285332S

SURFIX® screw and lock screw titanium dia. 3.5mm L.32mm

286330S

screw and locking screw - stainless steel dia. 3.5mm L.30mm

285334S

SURFIX® screw and lock screw titanium dia. 3.5mm L.34mm

286332S

screw and locking screw - stainless steel dia. 3.5mm L.32mm

285336S

SURFIX® screw and lock screw titanium dia. 3.5mm L.36mm

286334S

screw and locking screw - stainless steel dia. 3.5mm L.34mm

285338S

SURFIX® screw and lock screw titanium dia. 3.5mm L.38mm

286336S

screw and locking screw - stainless steel dia. 3.5mm L.36mm

285340S

SURFIX® screw and lock screw titanium dia. 3.5mm L.40mm

286338S

screw and locking screw - stainless steel dia. 3.5mm L.38mm

286340S

screw and locking screw - stainless steel dia. 3.5mm L.40mm

185300S

SURFIX® Lock screw titanium for dia. 3.5mm screw 186300S

Stainless steel locking screw for dia. 3.5mm screw

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

Mid & HindFoot

Instrument Reference

Description

CONTAINER UNI-CP™ 339950

CONTAINER QWIX® DIA 4.3MM Instruments tray for UNI-CP

™

119935

Instruments tray for QWIX® Ø4,3mm

Including the following components:

Including the following components :

339920

Instrument tray base

119936

Dia. 4,3mm base instruments set

169106

Cylinder

996400

Lid 22/17 Standard

996200

Lid

119937

Cylinder for screw dia. 4,3mm

INSTRUMENTATION UNI CP™

119938

Silicone carpet

219835

Hexagonal screwdriver for 3.5mm screw

INSTRUMENTATION QWIX® DIA 4.3

219435

AO hexagonal screwdriver 2mm

119138

Handle with AO quick attachment dia. 4,3mm

219635

Drilling guide for 3.5mm screw

119104

Screwdriver axis for dia. 4,3mm screw

219535

AO drill dia. 2.7mm L.125mm

119139

Short drill dia. 2.6mm for dia. 4,3mm screw

219735

Plate bender 3.5mm

115116

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

219335

Depth gauge for 3.5 mm screw

119516

4,0mm long cannulated drill

339001

Compression forceps

339003

Implant holder

339004

Implant sizer for T and U plates

339005

Implant sizer for 2 and 4 holes plates

115101

K-wire dia. 1.0mm L.100mm - 1 sharp

midfoot

: Available in spare part for replacement

UNI-CP™ Compression plate 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 Uni-CP™ «U» shaped plate is intended for arthrodesis of the 2nd and 3rd cuneo-metatarsal and the inter-cuneiform 2nd and 3rd joint. The size of the chosen staple should be adapted to the specific indication.

The UNI-CP™ Plates have to be fixed with the Surfix® fixed angle screws and lock screws diam. 3.5 mm. Material: 316LVM (ISO 5832-1 / ASTM F138&139) 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-CP is a trademark of Integra LifeSciences Corporation or its subsidiaries.

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

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: 01/2018.

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

25

Mid & HindFoot

Total Foot System II

Implant Reference

Description

PLATE

26

2801102

Lapidus Plate, 2 mm Step

2801103

Lapidus Plate, 3 mm Step

2801104

Lapidus Plate, 4 mm Step

2801105

Lapidus Plate, 5 mm Step

2801106

Lapidus Plate, 6 mm Step

2802100

Interpositioning Plate, Without Stem

2802102

Interpositioning Plate, 2 mm Stem

2802104

Interpositioning Plate, 4 mm Stem

2802106

Interpositioning Plate, 6 mm Stem

2802108

Interpositioning Plate, 8 mm Stem

2802110

Interpositioning Plate, 10 mm Stem

2802112

Interpositioning Plate, 12 mm Stem

2802014

Rear foot Universal Plate, 14 mm

2802016

Rear foot Universal Plate, 16 mm

2802018

Rear foot Universal Plate, 18 mm

2802020

Rear foot Universal Plate, 20 mm

2802022

Rear foot Universal Plate, 22 mm

2802024

Rear foot Universal Plate, 24 mm

2802030

Rear foot Universal Plate, 30 mm

2803007

Rear foot Reconstruction Plate, 34 mm, 7 Holes

2803009

Rear foot Reconstruction Plate, 54 mm, 9 Holes

2804014

Rear foot Reconstruction Plate, 66 mm, 14 Holes

2814004

Flat line Arthrodesis Plate, 12 mm

2814005

Flat line Arthrodesis Plate, 14 mm

2814006

Flat line Arthrodesis Plate, 16 mm

2806206

Dwyer Displacement Plate, 6 mm

2806208

Dwyer Displacement Plate, 8 mm

2806210

Dwyer Displacement Plate, 10 mm

2805006

Calcaneus Plate, Size Mini

2805007

Calcaneus Plate, Size Mini Long T

2815001

Calcaneus Plate, Size Small

2815002

Calcaneus Plate, Size Medium

2815004

Calcaneus Plate, Size Extra Small

2812003

Fibula Plate 3 hole

2812004

Fibula Plate 4 hole

2812005

Fibula Plate 5 hole

2813004

Fibula Tubular Plate 4 hole

2813006

Fibula Tubular Plate 6 hole

2813008

Fibula Tubular Plate 8 hole

LOCKING SCREW 2830012

3.5mm plate locking screw 12mm

2830014

3.5mm plate locking screw 14mm

2830016

3.5mm plate locking screw 16mm

2830018

3.5mm plate locking screw 18mm

2830020

3.5mm plate locking screw 20mm

2830022

3.5mm plate locking screw 22mm

2830024

3.5mm plate locking screw 24mm

2830026

3.5mm plate locking screw 26mm

2830028

3.5mm plate locking screw 28mm

2830030

3.5mm plate locking screw 30mm

2830032

3.5mm plate locking screw 32mm

2830035

3.5mm plate locking screw 35mm

2830040

3.5mm plate locking screw 40mm

2830045

3.5mm plate locking screw 45mm

2830050

3.5mm plate locking screw 50mm

LAG SCREW 2845112

3.5mm plate lag screw 12mm

2845114

3.5mm plate lag screw 14mm

2845116

3.5mm plate lag screw 16mm

2845118

3.5mm plate lag screw 18mm

2845120

3.5mm plate lag screw 20mm

2845122

3.5mm plate lag screw 22mm

2845124

3.5mm plate lag screw 24mm

2845126

3.5mm plate lag screw 26mm

2845128

3.5mm plate lag screw 28mm

2845130

3.5mm plate lag screw 30mm

2845132

3.5mm plate lag screw 32mm

2845135

3.5mm plate lag screw 35mm

2845140

3.5mm plate lag screw 40mm

2845145

3.5mm plate lag screw 45mm

2845150

3.5mm plate lag screw 50mm

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

Mid & HindFoot

Instrumentation Reference

Description

DRLTFS25

Drill Bit, 2.5 mm, w/AO (yellow)

DRLTFS35

Drill Bit, 3.5 mm w/AO (purple)

LDGTFS25

2.5 mm Screw on Drill Guide, 45 mm (yellow)

SDGTFS25

2.5 mm Snap on Drill Guide, 45 mm (yellow)

SDGTFS35

3.5 mm Snap on Drill Guide, 45 mm (purple)

2204157

Double Drill Guide Handle

HXDTFS25

2.5mm hex Driver, Non-Cannulated w/AO

RM1011S03

Ratcheting Handle w/AO QC (Green Pantone 347)

5010001

AO to Trinkle adapter

2204250

Plate & Screw Holding Forceps

2204262

Depth Gage For Plate Screws

2204124

Bending Pliers

KDFTFS00

K-wire Distraction/Compression Forceps

PBI80000

Plate Bending Iron

PBH80000

Plate bending Handles (Large)

RDGTFS01

Rearfoot Distraction Gage

321010

Reduction Bone Clamp

321012

Serrated Bone Clamp

CSA100111

Base Instrument Case

CSA00014

Generic Instrument Case Lid

CSA100113

Rearfoot Plates Caddy

CSA100114

Rearfoot Plates Caddy Lid

CSA100115

Rearfoot Screw Caddy

CSA100116

Rearfoot Screw Caddy Lid

CSA100117

Rearfoot Wires, Drills, & Drill guide Caddy

CSA100118

Rearfoot Wires, Drills, & Drill guide Caddy Lid

WIRE K-Wires 100 x 1.1 mm

2227711

Olive Wires 100 x 1.1 mm

2237811

K-Wires 100 x 1.6 mm

midfoot

2228611

Total Foot System Rearfoot Indications: The Integra® Total Foot System 2 (TFS2) is intended for skeletally mature patients for the following: • Stabilization and fixation of fresh fractures.• Intra-articular and extra-articular fractures, joint depression, and multi-fragmentary fractures.• Revision procedures, joint fusion and reconstruction of small bones of the feet.

Contraindications: • Plates and screws are contraindicated in: active infection, conditions which tend to retard healing such as blood supply limitations, previous infections, insufficient quantity or quality of bone to permit stabilization of the fracture complex,conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process and foreign body sensitivity.• Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.• Foreign body sensitivity – where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to implementations.• 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 non-unions in the presence of load bearing or weight bearing might eventually cause the implant to break due to metal fatigue. All metal surgical implants are subjected to repeated stress in use, which can result in metal fatigue.

Ascension Orthopedics, inc.

8700 Cameron road , Suite 100 Austin, Texas 78754 USA Phone: 512-836-5001

CE 0086

Total Foot System, Integra and the Integra logo are 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 device. 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.

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

• 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.

Integra LifeSciences Services (France) S.A.S. Immeuble Sequoia 2 97 Allée 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 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: 01/2018.

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

27

IntegraÂŽ Mid and HindFoot Ankle solutions

29

Mid & HindFoot

Advansys® TTC Fusion Plate Implant Reference

Description

PLATES

30

STAINLESS STEEL SCREW

181001S

TTC Plate right – 6 holes

286414S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.14mm

181002S

TTC Plate right – 8 holes

286416S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.16mm

181003S

TTC Plate right – 7 holes

286418S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.18mm

181004S

TTC Plate right – 9 holes

286420S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.20mm

181011S

TTC Plate left – 6 holes

286422S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.22mm

181012S

TTC Plate left – 8 holes

286424S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.24mm

181013S

TTC Plate left – 7 holes

286426S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.26mm

181014S

TTC Plate left – 9 holes

286428S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.28mm

TITANIUM SCREW

286430S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.30mm

285414S

SURFIX® screw and lock screw titanium dia. 4.5mm L.14mm

286435S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.35mm

285416S

SURFIX® screw and lock screw titanium dia. 4.5mm L.16mm

286450S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.50mm

285418S

SURFIX® screw and lock screw titanium dia. 4.5mm L.18mm

286455S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.55mm

285420S

SURFIX® screw and lock screw titanium dia. 4.5mm L.20mm

286460S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.60mm

285422S

SURFIX® screw and lock screw titanium dia. 4.5mm L.22mm

286465S

SURFIX® screw and lock screw stainless steel dia. 4.5mm L.65mm

285424S

SURFIX® screw and lock screw titanium dia. 4.5mm L.24mm

286620S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.20mm

285426S

SURFIX® screw and lock screw titanium dia. 4.5mm L.26mm

286625S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.25mm

285428S

SURFIX® screw and lock screw titanium dia. 4.5mm L.28mm

286630S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.30mm

285430S

SURFIX® screw and lock screw titanium dia. 4.5mm L.30mm

286635S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.35mm

285435S

SURFIX® screw and lock screw titanium dia. 4.5mm L.35mm

286640S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.40mm

285440S

SURFIX® screw and lock screw titanium dia. 4.5mm L.40mm

286645S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.45mm

285445S

SURFIX® screw and lock screw titanium dia. 4.5mm L.45mm

286650S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.50mm

285450S

SURFIX® screw and lock screw titanium dia. 4.5mm L.50mm

286655S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.55mm

285455S

SURFIX® screw and lock screw titanium dia. 4.5mm L.55mm

286660S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.60mm

285460S

SURFIX® screw and lock screw titanium dia. 4.5mm L.60mm

286665S

SURFIX® screw and lock screw stainless steel dia. 6.5mm L.65mm

285465S

SURFIX® screw and lock screw titanium dia. 4.5mm L.65mm

285620S

SURFIX® screw and lock screw titanium dia. 6.5mm L.20mm

186400S

SURFIX® Lock screw stainless steel for dia.4.5mm screw

285625S

SURFIX® screw and lock screw titanium dia. 6.5mm L.25mm

186600S

SURFIX® Lock screw stainless steel for dia.6.5mm screw

285630S

SURFIX® screw and lock screw titanium dia. 6.5mm L.30mm

285635S

SURFIX® screw and lock screw titanium dia. 6.5mm L.35mm

285640S

SURFIX® screw and lock screw titanium dia. 6.5mm L.40mm

285645S

SURFIX® screw and lock screw titanium dia. 6.5mm L.45mm

285650S

SURFIX® screw and lock screw titanium dia. 6.5mm L.50mm

285655S

SURFIX® screw and lock screw titanium dia. 6.5mm L.55mm

285660S

SURFIX® screw and lock screw titanium dia. 6.5mm L.60mm

285665S

SURFIX® screw and lock screw titanium dia. 6.5mm L.65mm

185400S

SURFIX® Lock screw titanium for dia.4.5mm screw

185600S

SURFIX® Lock screw titanium for dia.6.5mm screw

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

Mid & HindFoot

Instrument Reference

Description

CONTAINER 169 101

Instruments tray for ADVANSYS® TTC

Including the following components: 169 111

Basis

996 200

Lid

169 104

Cylinder

169 105

Rack

119 909

4 Blue silicone wedges

INSTRUMENTATION 219 845

Hexagonal screwdriver for 4.5mm screw

219 865

Hexagonal screwdriver for 6.5mm screw

219 445

AO hexagonal screwdriver 2.5mm

219 465

AO hexagonal screwdriver 3.5mm

219 645

Drilling guide for 4.5mm screw

219 665

Drilling guide for 6.5mm screw

219 545

AO drill dia. 3.0mm L.190mm

219 565

AO drill dia. 3.5mm L.200mm

219 900

Axial compression clamp

219 765

Plate bender 6.5 mm

219 345

Depth gauge for 4.5mm screw

219 365

Depth gauge for 6.5mm screw

169 001

Trial plate 6 holes

169 002

Trial plate 8 holes

169 003

Trial plate 7 holes

169 004

Trial plate 9 holes

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

115 425

K-wire dia. 2.5mm L.200mm - 1 sharp

: Available in spare part for replacement midfoot

115 116

Advansys® TTC Fusion Plate Indications: - TTC Plate (Tibio-Talocalcaneus Plate) indications: For arthrodesis of the ankle joint and distal tibia, fractures, osteotomies, fusions and replantations of small bones in the foot and ankle. The Advansys® TTC Plate have to be fixed with the Surfix® fixed angle screws and lock screws 4.5 mm and 6.5 mm diameters. Material: 316LVM (ISO 5832-1 / ASTM F138 & F139).

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. Advansys 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

CE 0120

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: 02/2018.

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

31

Mid & HindFoot

PANTA® / PANTA® XL Arthrodesis Nail Implant Reference

FULLY THREADED SCREW Description

NAILS

32

501020

Fully threaded screw dia. 5mm L.20mm

501022

Fully threaded screw dia. 5mm L.22,5mm

500050

Nail dia. 10mm L.150mm

501025

Fully threaded screw dia. 5mm L.25mm

500080

Nail dia. 10mm L.180mm

501027

Fully threaded screw dia. 5mm L.27,5mm

500150

Nail dia. 11mm L.150mm

501030

Fully threaded screw dia. 5mm L.30mm

500180

Nail dia. 11mm L.180mm

501035

Fully threaded screw dia. 5mm L.35mm

500250

Nail dia. 12mm L.150mm

501040

Fully threaded screw dia. 5mm L.40mm

500280

Nail dia. 12mm L.180mm

501045

Fully threaded screw dia. 5mm L.45mm

500350

Nail dia. 13mm L.150mm

501050

Fully threaded screw dia. 5mm L.50mm

500380

Nail dia. 13mm L.180mm

501055

Fully threaded screw dia. 5mm L.55mm

501060

Fully threaded screw dia. 5mm L.60mm

501065

Fully threaded screw dia. 5mm L.65mm

501070

Fully threaded screw dia. 5mm L.70mm

501075

Fully threaded screw dia. 5mm L.75mm

501080

Fully threaded screw dia. 5mm L.80mm

501085

Fully threaded screw dia. 5mm L.85mm

501090

Fully threaded screw dia. 5mm L.90mm

501095

Fully threaded screw dia. 5mm L.95mm

501100

Fully threaded screw dia. 5mm L.100mm

501105

Fully threaded screw dia. 5mm L.105mm

XL NAILS

501110

Fully threaded screw dia. 5mm L.110mm

510111

Dynamic XL nail dia. 11mm L.210mm

PARTIALLY THREADED SCREW

510141

Dynamic XL nail dia. 11mm L.240mm

511020

Partially threaded screw dia. 5mm L.20mm

510211

Dynamic XL nail dia. 12mm L.210mm

511022

Partially threaded screw dia. 5mm L.22,5mm

510241

Dynamic XL nail dia. 12mm L.240mm

511025

Partially threaded screw dia. 5mm L.25mm

510311

Dynamic XL nail dia. 13mm L.210mm

511027

Partially threaded screw dia. 5mm L.27,5mm

510341

Dynamic XL nail dia. 13mm L.240mm

511030

Partially threaded screw dia. 5mm L.30mm

500001

End cap

511035

Partially threaded screw dia. 5mm L.35mm

510005

Long end cap

511040

Partially threaded screw dia. 5mm L.40mm

511045

Partially threaded screw dia. 5mm L.45mm

511050

Partially threaded screw dia. 5mm L.50mm

511055

Partially threaded screw dia. 5mm L.55mm

511060

Partially threaded screw dia. 5mm L.60mm

511065

Partially threaded screw dia. 5mm L.65mm

511070

Partially threaded screw dia. 5mm L.70mm

511075

Partially threaded screw dia. 5mm L.75mm

511080

Partially threaded screw dia. 5mm L.80mm

511085

Partially threaded screw dia. 5mm L.85mm

511090

Partially threaded screw dia. 5mm L.90mm

511095

Partially threaded screw dia. 5mm L.95mm

511100

Partially threaded screw dia. 5mm L.100mm

511105

Partially threaded screw dia. 5mm L.105mm

511110

Partially threaded screw dia. 5mm L.110mm

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

Mid & HindFoot

Instrument Reference

INSTRUMENTATION Description

CONTAINER 519900

Instruments tray for PANTA®

Including the following components: 519910

Sterilization container

519911

Reamers tray

996300

Standard Lid 1DIN

119909

4 Blue silicone wedges

519912

Reamer holder

519002

Lengthened medium drill for calcaneum screws dia. 4.3mm

519003

Drill for calcaneum screws dia. 4.3mm (optional)

519004

Drill for tibial screws dia. 4.3mm

519005

Drill dia. 5mm

519006

Long drill for calcaneum screws dia. 4.3mm (optional)

519007

Cannulated drill dia. 7mm

519008

Medium drill for calcaneum screws dia. 4.3mm

519009

Cannulated drill dia. 9mm

midfoot

: Available in spare part for replacement

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

33

Mid & HindFoot

519010

Reamer dia. 10mm (optional)

519130

Compression instrument

519011

Reamer dia. 11mm

519131

Threaded axis

519012

Reamer dia. 12mm

519133

Plastic ring

519013

Reamer dia. 13mm

519135

Compression wheel

519014

Reamer dia. 10.5mm

519160

Depth gauge

519015

Reamer dia. 11.5mm

519175

Compression rod

519016

Reamer dia. 12.5mm

519178

Medium drilling guide dia. 4.3mm

519017

Reamer dia. 13.5mm

519179

Short drilling guide dia. 4.3mm (optional)

519021

T-handle AO attachment

519180

Drilling guide dia. 4.3mm

519028

Protecting sleeve dia. 3.2mm

519181

Drilling guide dia. 5mm

519029

Protecting sleeve dia. 9mm

519183

Medium protecting sleeve dia. 7mm

519030

Protecting sleeve dia. 13.5mm

519184

Short protecting sleeve dia. 7mm (optional)

519032

Guide pin dia. 3.2mm L.400mm

519185

Drilling guide dia. 7mm

519034

Guide pin dia.3.2mm L.600mm

519290

Hexagonal screwdriver tip 3.5mm

519040

Trocar Awl

519295

Hexagonal screwdriver 3.5mm

519110

Support device

519020

Quick coupling AO

519120

Nail fixation axis

539015

Tap

519121

Toothed wheel

PANTA® / PANTA® XL Arthrodesis Nail Indications: The PANTA® Ankle Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: -Post-traumatic and degenerative arthritis involving both ankle and subtalar joints -Rheumatoid arthritis -Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body -Revision of failed total ankle arthroplasty with subtalar intrusion -Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -Avascular necrosis of the talus -Neuroarthropathy or neuropathic ankle deformity -Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease -Severe pilon fractures with trauma to the subtalar joint.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -intact asymptomatic subtalar joint -active local or systemic infection -severe peripheral vascular disease -severe longitudinal deformity -insufficient quantity or quality of bone to permit stabilization of the arthrodesis -obliterated medullary canal or other conditions which tend to retard healing such as blood supply limitations, previous infections... -conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process -insufficient plantar pad -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. 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.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Panta 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: 01/2018.

34

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

Mid & HindFoot

PANTA® Removal Set Instrumentation Reference

Description

CONTAINER 519950

Instruments tray for PANTA® Removal

Including the following components: 519951

Basis

996100

Lid standard

INSTRUMENTATION 519209

Sliding Hammer

519210

Extractor Holder

309645

Hexagonal screwdriver 3.5mm

119552

6,5mm external protecting sleeve : Available in spare part for replacement

Indications: The PANTA® Ankle Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: -Post-traumatic and degenerative arthritis involving both ankle and subtalar joints -Rheumatoid arthritis -Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body -Revision of failed total ankle arthroplasty with subtalar intrusion -Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -Avascular necrosis of the talus -Neuroarthropathy or neuropathic ankle deformity -Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease -Severe pilon fractures with trauma to the subtalar joint.

Contraindications: The implant should not be used in a patient who has currently, or who has a history of: -intact asymptomatic subtalar joint -active local or systemic infection -severe peripheral vascular disease -severe longitudinal deformity -insufficient quantity or quality of bone to permit stabilization of the arthrodesis -obliterated medullary canal or other conditions which tend to retard healing such as blood supply limitations, previous infections... -conditions that restrict the patient’s ability or willingness to follow postoperative instructions during the healing process -insufficient plantar pad -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. 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

midfoot

PANTA® Removal Set

CE 0120

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Panta 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 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: 02/2018.

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

35

Mid & HindFoot

TIBIAXYS® Ankle Arthrodesis Plating System Implant Reference

Description

PLATES

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.10mm

295312S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.12mm

295314S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.14mm

150010S

Left Medial Anterior Tibial Plate

295316S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.16mm

150020S

Left Lateral Anterior Tibial Plate

295318S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.18mm

150110S

Right Medial Anterior Tibial Plate

295320S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.20mm

150120S

Right Lateral Anterior Tibial Plate

295322S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.22mm

SCREWS

36

295310S

295324S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.24mm

150240S

Cortical screw dia. 4mm L.40mm

295326S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.26mm

150242S

Cortical screw dia. 4mm L.42mm

295328S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.28mm

150246S

Cortical screw dia. 4mm L.46mm

295330S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.30mm

150250S

Cortical screw dia. 4mm L.50mm

295332S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.32mm

150255S

Cortical screw dia. 4mm L.55mm

295334S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.34mm

150260S

Cortical screw dia. 4mm L.60mm

295336S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.36mm

150265S

Cortical screw dia. 4mm L.65mm

295338S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.38mm

150270S

Cortical screw dia. 4mm L.70mm

295340S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.40mm

150275S

Cortical screw dia. 4mm L.75mm

295344S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.44mm

150280S

Cortical screw dia. 4mm L.80mm

295346S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.46mm

150285S

Cortical screw dia. 4mm L.85mm

295348S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.48mm

150290S

Cortical screw dia. 4mm L.90mm

295350S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.50mm

150200S

Cortical screw dia. 4mm L.100mm 185300S

SURFIX® Lock screw titanium for dia. 3.5mm screw

285310S

SURFIX® screw and lock screw titanium dia. 3.5mm L.10mm

195300S

SURFIX® Alpha Lock screw titanium dia. 3.5mm

285312S

SURFIX® screw and lock screw titanium dia. 3.5mm L.12mm

285314S

SURFIX® screw and lock screw titanium dia. 3.5mm L.14mm

285316S

SURFIX® screw and lock screw titanium dia. 3.5mm L.16mm

285318S

SURFIX® screw and lock screw titanium dia. 3.5mm L.18mm

285320S

SURFIX® screw and lock screw titanium dia. 3.5mm L.20mm

285322S

SURFIX® screw and lock screw titanium dia. 3.5mm L.22mm

285324S

SURFIX® screw and lock screw titanium dia. 3.5mm L.24mm

285326S

SURFIX® screw and lock screw titanium dia. 3.5mm L.26mm

285328S

SURFIX® screw and lock screw titanium dia. 3.5mm L.28mm

285330S

SURFIX® screw and lock screw titanium dia. 3.5mm L.30mm

285332S

SURFIX® screw and lock screw titanium dia. 3.5mm L.32mm

285334S

SURFIX® screw and lock screw titanium dia. 3.5mm L.34mm

285336S

SURFIX® screw and lock screw titanium dia. 3.5mm L.36mm

285338S

SURFIX® screw and lock screw titanium dia. 3.5mm L.38mm

285340S

SURFIX® screw and lock screw titanium dia. 3.5mm L.40mm

285344S

SURFIX® screw and lock screw titanium dia. 3.5mm L.44mm

285346S

SURFIX® screw and lock screw titanium dia. 3.5mm L.46mm

285348S

SURFIX® screw and lock screw titanium dia. 3.5mm L.48mm

285350S

SURFIX® screw and lock screw titanium dia. 3.5mm L.50mm

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

Mid & HindFoot

Instrument Reference

Description

STERILIZATION CONTAINER FOR TRIAL IMPLANT

219035

Drilling guide for variable angle screw dia.3.5mm

159970

Container for trial implants

159400

Depth gauge dia.4mm screws

Including the following components:

219335

Depth gauge for 3.5 mm screw

159971

Base of the trial implants

159010

Left medial anterior trial plate

309942

Pins box lid

159020

Left lateral anterior trial plate

STERILIZATION CONTAINER FOR TIBIAXYS

159110

Right medial anterior trial plate

159991

159120

Right lateral anterior trial plate

Instruments tray for TIBIAXYS®

Including the following components:

K-WIRE

119909

4 Blue silicone wedges

115116

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

159960

Sterilization container assembled base

115225

Graduated K-wire dia. 2.5mm L.200mm - 1 sharp

996200

Lid

: Available in spare part for replacement

219635

Drilling guide for 3.5mm screw

159103

Wedge thickness 3mm

159106

Wedge thickness 6mm

159109

Wedge thickness 9mm

159130

Drilling guide dia.3mm

219960

Compression forceps

159635

Drilling guide for compression forceps

159740

Screw for compression forceps dia.4 L.40mm

159755

Screw for compression forceps dia.4 L.55mm

159760

Screw for compression forceps dia.4 L.60mm

219535

AO drill dia. 2.7mm L.125mm

219545

AO drill dia. 3.0mm L.190mm

219835

Hexagonal screwdriver for 3.5mm screw

219435

AO hexagonal screwdriver 2mm

219845

Hexagonal screwdriver for 4.5mm screw

219445

AO hexagonal screwdriver 2.5mm

219135

Screwdriver Torx 10 midfoot

INSTRUMENTATION

TIBIAXYS® Ankle Arthrodesis Plating System Indications: For the fixation of bone fractures or for bone reconstruction. Intended use: arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula. TIBIAXYS® plates must be fixed with the Surfix® fixed angle locking system and with the Surfix® -Alpha variable angle locking system of 3.5mm diameter (screws and Lock screws). Anterior plates for ankle arthrodesis must be fixed with Tibiaxys® Plating System 4 mm diameter cortical screws. The Surfix® and Surfix®- Alpha locking systems (screws and lock screws) used with the TIBIAXYS® plates must be manufactured from titanium alloy (Ti-6Al-4V).

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. Tibiaxys 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

CE 0120

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: 02/2018.

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

37

Mid & HindFoot

Distal osteotomy Implant Reference

Description

PLATES 150040S

Medial Tibial Plate

150030S

Lateral right / medial left tibial plate

150130S

Medial right / lateral left tibial plate

150514S

Fibula Plate 4 holes

150516S

Fibula Plate 6 holes

SCREWS

38

285310S

SURFIX® screw and lock screw titanium dia. 3.5mm L.10mm

295310S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.10mm

285312S

SURFIX® screw and lock screw titanium dia. 3.5mm L.12mm

295312S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.12mm

285314S

SURFIX® screw and lock screw titanium dia. 3.5mm L.14mm

295314S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.14mm

285316S

SURFIX® screw and lock screw titanium dia. 3.5mm L.16mm

295316S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.16mm

285318S

SURFIX® screw and lock screw titanium dia. 3.5mm L.18mm

295318S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.18mm

285320S

SURFIX® screw and lock screw titanium dia. 3.5mm L.20mm

295320S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.20mm

285322S

SURFIX® screw and lock screw titanium dia. 3.5mm L.22mm

295322S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.22mm

285324S

SURFIX® screw and lock screw titanium dia. 3.5mm L.24mm

295324S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.24mm

285326S

SURFIX® screw and lock screw titanium dia. 3.5mm L.26mm

295326S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.26mm

285328S

SURFIX® screw and lock screw titanium dia. 3.5mm L.28mm

295328S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.28mm

285330S

SURFIX® screw and lock screw titanium dia. 3.5mm L.30mm

295330S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.30mm

285332S

SURFIX® screw and lock screw titanium dia. 3.5mm L.32mm

295332S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.32mm

285334S

SURFIX® screw and lock screw titanium dia. 3.5mm L.34mm

295334S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.34mm

285336S

SURFIX® screw and lock screw titanium dia. 3.5mm L.36mm

295336S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.36mm

285338S

SURFIX® screw and lock screw titanium dia. 3.5mm L.38mm

295338S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.38mm

285340S

SURFIX® screw and lock screw titanium dia. 3.5mm L.40mm

295340S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.40mm

285344S

SURFIX® screw and lock screw titanium dia. 3.5mm L.44mm

295344S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.44mm

285346S

SURFIX® screw and lock screw titanium dia. 3.5mm L.46mm

295346S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.46mm

285348S

SURFIX® screw and lock screw titanium dia. 3.5mm L.48mm

295348S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.48mm

285350S

SURFIX® screw and lock screw titanium dia. 3.5mm L.50mm

295350S

SURFIX® Alpha screw and lock screw titanium dia. 3.5mm L.50mm

185300S

SURFIX® Lock screw titanium for dia. 3.5mm screw

195300S

SURFIX® Alpha Lock screw titanium dia. 3.5mm

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

Mid & HindFoot

Instrument Reference

Description

STERILIZATION CONTAINER FOR TRIAL IMPLANT

219035

Drilling guide for variable angle screw dia.3.5mm

159970

Container for trial implants

159400

Depth gauge dia.4mm screws

Including the following components:

219335

Depth gauge for 3.5 mm screw

159971

Base of the trial implants

159010

Left medial anterior trial plate

309942

Pins box lid

159020

Left lateral anterior trial plate

STERILIZATION CONTAINER FOR TIBIAXYS

159110

Right medial anterior trial plate

159991

159120

Right lateral anterior trial plate

Instruments tray for TIBIAXYS®

Including the following components:

K-WIRE

119909

4 Blue silicone wedges

115116

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

159960

Sterilization container assembled base

115225

Graduated K-wire dia. 2.5mm L.200mm - 1 sharp

996200

Lid

219635

Drilling guide for 3.5mm screw

159103

Wedge thickness 3mm

159106

Wedge thickness 6mm

159109

Wedge thickness 9mm

159130

Drilling guide dia.3mm

219960

Compression forceps

159635

Drilling guide for compression forceps

159740

Screw for compression forceps dia.4 L.40mm

159755

Screw for compression forceps dia.4 L.55mm

159760

Screw for compression forceps dia.4 L.60mm

219535

Drill dia. 2.7mm L.125mm

219545

Drill dia. 3.0mm L.190mm

219835

Hexagonal screwdriver for 3.5mm screw

219435

AO hexagonal screwdriver 3.5mm screw

219845

Hexagonal screwdriver for 4.5mm screw

219445

AO hexagonal screwdriver 4.5mm screw

219135

Screwdriver Torx 10

: Available in spare part for replacement

midfoot

INSTRUMENTATION

TIBIAXYS® Distal Tibia and Fibula Osteotomy Plating Systems Indications: For the fixation of bone fractures or for bone reconstruction. Intended use: arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula. TIBIAXYS® plates must be fixed with the Surfix® fixed angle locking system and with the Surfix® -Alpha variable angle locking system of 3.5mm diameter (screws and Lock screws). Anterior plates for ankle arthrodesis must be fixed with Tibiaxys® Plating System 4 mm diameter cortical screws. The Surfix® and Surfix®- Alpha locking systems (screws and lock screws) used with the TIBIAXYS® plates must be manufactured from titanium alloy (Ti-6Al-4V).

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. Tibiaxys 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

CE 0120

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: 02/2018.

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

39

IntegraÂŽ Mid and HindFoot Sport medicine

41

Mid & HindFoot

ACHILLON® Minimal Invasive Achilles Tendon Suture System Implant Reference

Description

119700

Minimally invasive Achilles tendon suture system Achillon®

119720

3 needles set for Achillon® system

ACHILLON® Minimal Invasive Achilles Tendon Suture System Indications: Acute (less than 10 days) closed ruptures of the Achilles tendon. Open ruptures (less than 6 hours) without skin defect. Rupture located between 2 cm and 8 cm above the tuberosity of the calcaneum.

Contraindications: The instrument should not be used in a patient who has currently, or who has history of : -Chronic rupture. -previous local surgery. -patient under steroids -Open ruptures (more than 6 hours) -Complex open ruptures with skin defect. -Pediatric age -Rupture located between 0 and 2 cm above the tuberosity of the calcaneum and higher then 8 cm above the tuberosity of the calcaneum. -Non collaborating patient -Patient unable to walk with crutches. Each patient must be evaluated by the surgeon to determine the specific risk/benefit relationship in light of the patient’s condition and the surgeon’s practice, training, experience, and knowledge of the related medical literature. Complications with the use of similar surgical technic have been reported in the medical literature. Any patient undergoing a surgical procedure is subject to intra-operative and post-operative complications. Each patient’s tolerance to surgery, medication, and implantation of a foreign object may be different.Possible risks, adverse reactions, and complications associated with surgery and the use of this surgical technique should be discussed with and understood by the patient prior to surgery. The patient should not be led to unrealistic expectations as to the performance or results that the surgery can provide. The patient should be informed that successful results cannot be guaranteed. It is the responsibility of the surgeon to provide the patient with information prior to surgery Complications may include but are not limited to : -Pain, discomfort, or abnormal sensations; -Risk of additionnal injury from post-operative trauma. Side effects may include but are not limited to : -Infections -Hematoma -Allergy -Skin necrosis -Venous Thrombosis Adverse effects may necessitate re-operation.

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

Products mentioned in this document are CE class 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: 02/2018.

42

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

midfoot

Mid & HindFoot

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

43

IntegraÂŽ Mid and HindFoot Instruments

45

Mid & HindFoot

Removal instruments for ADVANSYS® Medial Lisfranc Plate, ADVANSYS® Dorsal Lisfranc Plate, ADVANSYS® TTC Fusion Plate, TIBIAXYS® Ankle Arthrodesis Plating System, TIBIAXYS® Distal Tibia and Fibula Osteotomy Plating Systems and UNI-CP™ Compression plate Instrumentation Reference

Description

MA3511

Screws extractor

219135

Screwdriver Torx 10

219435

AO hexagonal screwdriver 2mm

219835

Hexagonal screwdriver for 3.5mm screw

219445

AO hexagonal screwdriver 2.5mm

219845

Hexagonal screwdriver for 4.5mm screw

219865

Hexagonal screwdriver for 6.5mm screw

219465

AO hexagonal screwdriver 3.5mm

Removal instruments for ADVANSYS® Medial Lisfranc Plate, ADVANSYS® Dorsal Lisfranc Plate, ADVANSYS® TTC Fusion Plate, TIBIAXYS® Ankle Arthrodesis Plating System, TIBIAXYS® Distal Tibia and Fibula Osteotomy Plating Systems and UNI-CP™ Compression plate Indications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Neweal 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 sugery. Only a sugeon 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.

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 and Class 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: 02/2018.

46

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

CE 0120

Mid & HindFoot

Integra distraction forceps Instrument Reference

Description

119664

Large Integra distraction Forceps 21cm Outspread Arms

119653

Small Integra distraction Forceps 15cm Outspread Arms

119654

Small Integra distraction Forceps 15cm Closed Arms

119651

Large Integra distraction Forceps 21 cm Closed arms

997400

Compression forceps

WIRE & GUIDE PIN K-wire dia. 1.6mm L.150mm - 1 sharp

115225

Graduated K-wire dia. 2.5mm L.200mm - 1 sharp

519032

Guide pin dia. 3.2mm L.400mm

midfoot

115116

Integra distraction forceps Indications: These instruments are intended for use in surgery, and should be used only for the introduction of associated Neweal 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 sugery. Only a sugeon 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.

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 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.

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: 02/2018.

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

47

Mid & HindFoot

48

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

midfoot

Mid & HindFoot

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

49

Mid & HindFoot

50

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

Integra® Mid and HindFoot 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: 02/2018. 0881969-2-EN DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY.