CATALOG SOLUTII MEMBRU SUPERIOR( UMAR, COT) INTEGRA by ENLIFE SOLUTIONS by ENLIFE SOLUTIONS

IntegraÂŽ Upper Extremity Solutions Product Catalogue Finger, Nerve and Wrist

Table of content

Finger PyroCarbon PIP implant PIP �� 6 Silicone PIP implant SPIP �� 8 PyroCarbon and Silicone MCP implant MCP & SMCP ��10 Pyrodisk™ CMC PyroCarbon stabilized spacer ��12 NuGrip™ CMC PyroCarbon hemi arthroplasty implant �� 13 PyroSphere™ - Pyrocarbon™ CMC spacer PCS ��14 Nerve EndoRelease™ endoscopic cubital tunnel release system �� 17 Safeguard™ mini-open carpal tunnel release system ��18 Wrist Freedom Wrist System - total or hemi wrist replacement system ��21 Universal 2™ total wrist implant system ��23 Integra® total wrist fusion system ITWFS �� 25 PyroCarbon lunate implant ��27 First Choice™ Distal Radio Ulnar Joint system and Modular Ulnar Head system DRUJ & MUH �� 29 Spider™ - Mini Spider™ / limited wrist fusion system - Titanium �� 31 Spider™ - Mini Spider™ / limited wrist fusion system - Stainless Steel �� 32 WIFIX® Plate - Surfix® volar plate for distal radius ��33

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

IntegraÂŽ Upper Extremity Finger

Finger

PyroCarbon PIP implant PIP Implants

Reference

Description

PIP-200-10D-WW

Proximal Interphalangeal Sz 10 Distal

PIP-200-10P-WW

Proximal Interphalangeal Sz 10 Proximal

PIP-200-20D-WW

Proximal Interphalangeal Sz 20 Distal

PIP-200-20P-WW

Proximal Interphalangeal Sz 20 Proximal

PIP-200-30D-WW

Proximal Interphalangeal Sz 30 Distal

PIP-200-30P-WW

Proximal Interphalangeal Sz 30 Proximal

PIP-200-40D-WW

Proximal Interphalangeal Sz 40 Distal

PIP-200-40P-WW

Proximal Interphalangeal Sz 40 Proximal

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

Finger

Instruments Reference

Description

OSG-200-10P

PIP, Proximal Cut Guide, Sz. 10

BRH-200-40P

PIP, Cutting Broach, Proximal, Sz. 40

OSG-200-20P

PIP, Proximal Cut Guide, Sz. 20

AWL-200-00

PIP Alignment Awl

OSG-200-30P

PIP, Proximal Cut Guide, Sz. 30

OSG-200-40P

PIP, Proximal Cut Guide, Sz. 40

Optional instruments

IMP-200-00D

PIP, Impactor, Distal

Reference

Description

IMP-200-00P

PIP, Impactor, Proximal

OSG-200-10PV

PIP Volar approach osteotemy guide, Size 10

TRL-202-10D

PIP Distal Ti Trial Sz. 10

OSG-200-20PV

PIP Volar approach osteotemy guide, Size 20

TRL-202-10P

PIP Proximal Ti Trial Sz. 10

OSG-200-30PV

PIP Volar approach osteotemy guide, Size 30

TRL-202-20D

PIP Distal Ti Trial Sz. 20

OSG-200-40PV

PIP Volar approach osteotemy guide, Size 40

TRL-202-20P

PIP Proximal Ti Trial Sz. 20

TRL-202-30D

PIP Distal Ti Trial Sz. 30

TRL-202-30P

PIP Proximal Ti Trial Sz. 30

TRL-202-40D

PIP Distal Ti Trial Sz. 40

TRL-202-40P

PIP Proximal Ti Trial Sz. 40

OSG-200-00

PIP Vertical Cut Guide

CSA-200-02

Instrument Base

CSA-200-03

Instrument Insert

TMP-200-01

PIP Distal Template

ALG-100-00

Alignment Guide, E/M

EXT-200-00

Extractor

AWL-100-01

Awl, Starter

BRH-200-10D

PIP, Cutting Broach, Distal, Sz. 10

BRH-200-10P

PIP, Cutting Broach, Proximal, Sz. 10

BRH-200-20D

PIP, Cutting Broach, Distal, Sz. 20

BRH200-30D

PIP, Cutting Broach, Distal, Sz. 30

BRH-200-40D

PIP, Cutting Broach, Distal, Sz. 40

CSA-000-01

Insturment Lid

BRH-200-20P

PIP, Cutting Broach, Proximal, Sz. 20

BRH-200-30P

PIP, Cutting Broach, Proximal, Sz. 30

Pyrocarbon PIP Implant Indications: Pyrocarbon proximal interphalangeal (PIP) implant indications: Pyrocarbon PIP is indicated for use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: • Has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and • Needs a revision of a failed PIP prosthesis, or has pain,limited motion, or joint subluxation/dislocation secondary to damage or destruction of the articular cartilage. Contraindications: Inadequate bone stock at the implantation site ; Active infection in the PIP joint ; Nonfunctioning and irreparable PIP musculotendinous system ; Physical interference with or by other prostheses during implantation or use ; Procedures requiring modification of the prosthesis ; Skin, bone, circulatory and/or neurological deficiency at the implantation site. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Products mentioned in this document are CE class I, IIa and IIb 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.

Ascension Orthopedics, inc. 8700 Cameron road , Suite 100 Austin, Texas 78754 USA Phone: 512-836-5001 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 00 Fax: +33(0)4 37 47 59 30

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

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

Finger

Silicone PIP implant SPIP Implant

Reference

Description

SPIP-520-2-WW

Silicone PIP, Sz 0

SPIP-520-0-WW

Silicone PIP, Sz 1

SPIP-520-1-WW

Silicone PIP, Sz 2

SPIP-520-3-WW

Silicone PIP, Sz 3

SPIP-520-4-WW

Silicone PIP, Sz 4

SPIP-520-5-WW

Silicone PIP, Sz 5

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

Finger

Instrument Reference

Description

ALG-100-00

ALIGNMENT GUIDE, E/M

AWL-100-01

AWL, STARTER

AWL-200-00

PIP ALIGNMENT AWL

BRH-525-0D

SILICONE PIP DISTAL BROACH SZ. 0

BRH-525-0P

SILICONE PIP PROXIMAL BROACH SZ. 0

BRH-525-1D

SILICONE PIP DISTAL BROACH SZ. 1

BRH-525-1P

SILICONE PIP PROXIMAL BROACH SZ. 1

BRH-525-2D

SILICONE PIP DISTAL BROACH SZ. 2

BRH-525-2P

SILICONE PIP PROXIMAL BROACH SZ. 2

BRH-525-3D

SILICONE PIP DISTAL BROACH SZ. 3

BRH-525-3P

SILICONE PIP PROXIMAL BROACH SZ. 3

BRH-525-4D

SILICONE PIP DISTAL BROACH SZ. 4

BRH-525-4P

SILICONE PIP PROXIMAL BROACH SZ. 4

BRH-525-5D

SILICONE PIP DISTAL BROACH SZ. 5

BRH-525-5P

SILICONE PIP PROXIMAL BROACH SZ. 5

CSA-000-04

CASE LID

CSA-520-05

SPIP BASE

CSA-520-06

SPIP TRIAL CADDY LID

CSA-520-07

SPIP TRIAL CADDY (CASE)

OSG-442-00

THB VERTICAL CUT GUIDE

TRL-520-0

SILICONE PIP SIZING TRIAL SZ. 0

TRL-520-1

SILICONE PIP SIZING TRIAL SZ. 1

TRL-520-2

SILICONE PIP SIZING TRIAL SZ. 2

TRL-520-3

SILICONE PIP SIZING TRIAL SZ. 3

TRL-520-4

SILICONE PIP SIZING TRIAL SZ. 4

TRL-520-5

SILICONE PIP SIZING TRIAL SZ. 5

Silicone implant SPIP Indications: The Ascension Silicone PIP Finger Joint Prosthesis is intended for cementless replacement of the proximal interphalangeal (PIP) joint where disabled by rheumotoid, degenerative, or traumatic arthritis. Contraindications: Active local or systemic infection ; Destruction of the metacarpal, phalanx, or phalanges or poor bone quality which prevents adequate fixation of the implant ; Loss of musculature, neuromuscular compromise, or vascular deficiency in the affected fingers ; Growing patients with open epiphyses ; Patient with high activity levels ; and patients unwilling or unable to comply with physician’s instructions. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Products mentioned in this document are CE class I, IIa and IIb 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.

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

Finger

PyroCarbon and Silicone MCP implant MCP & SMCP Implants Reference

Description

PyroCarbone implants MCP-110-05D-WW

Metacarpophalangeal Joint – Size 05, Distal

MCP-100-10D-WW

Metacarpophalangeal Joint – Size 10, Distal

MCP-100-20D-WW

Metacarpophalangeal Joint – Size 20, Distal

MCP-100-30D-WW

Metacarpophalangeal Joint – Size 30, Distal

MCP-100-40D-WW

Metacarpophalangeal Joint – Size 40, Distal

MCP-110-05P-WW

Metacarpophalangeal Joint – Sz 05, Proximal

MCP-100-10P-WW

Metacarpophalangeal Joint – Sz 10, Proximal

MCP-100-20P-WW

Metacarpophalangeal Joint – Sz 20, Proximal

MCP-100-30P-WW

Metacarpophalangeal Joint – Sz 30, Proximal

MCP-100-40P-WW

Metacarpophalangeal Joint – Sz 40, Proximal

Silicone implants SMCP-500-05-WW

Silicone MCP, Sz 05

SMCP-500-10-WW

Silicone MCP, Sz 10

SMCP-500-20-WW

Silicone MCP, Sz 20

SMCP-500-30-WW

Silicone MCP, Sz 30

SMCP-500-40-WW

Silicone MCP, Sz 40

Instruments

Reference

Description

BRH-101-05D

MCP Distal Broach Sz. 05 (Cutting)

TRL-500-10

SMCP Trial Sz 10

BRH-101-05P

MCP Proximal Broach Sz. 05 (Cutting)

TRL-500-20

SMCP Trial Sz 20

IMP-100-00D

MCP, Impactor, Distal

TRL-500-30

SMCP Trial Sz 30

IMP-100-00P

MCP, Impactor, Proximal

TRL-500-40

SMCP Trial Sz 40

OSG-100-00D

MCP, Osteotomy Guide, Distal

EXT-100-01

MCP, Extractor, Implant

OSG-100-00P

MCP, Osteotomy Guide, Proximal

BRH-100-10D

MCP, Broach, Distal, Sz. 10

TRL-101-05D

MCP Distal Trial Sz. 05 (METAL)

BRH-100-10P

MCP, Broach, Proximal, Sz. 10

TRL-101-05P

MCP Proximal Trial Sz. 05 (METAL)

BRH-100-20D

MCP, Broach, Distal, Sz. 20

TRL-101-10D

MCP, Trial, Distal, Sz. 10 (METAL)

BRH-100-20P

MCP, Broach, Proximal, Sz. 20

TRL-101-10P

MCP, Trial, Proximal, Sz. 10 (METAL)

BRH-100-30D

MCP, Broach, Distal, Sz. 30

TRL-101-20D

MCP, Trial, Distal, Sz. 20 (METAL)

BRH-100-30P

MCP, Broach, Proximal, Sz. 30

TRL-101-20P

MCP, Trial, Proximal, Sz. 20 (METAL)

BRH-100-40D

MCP, Broach, Distal, Sz. 40

TRL-101-30D

MCP, Trial, Distal, Sz. 30 (METAL)

BRH-100-40P

MCP, Broach, Proximal, Sz. 40

TRL-101-30P

MCP, Trial, Proximal, Sz. 30 (METAL)

ALG-100-00

Alignment Guide, E/M

TRL-101-40D

MCP, Trial, Distal, Sz. 40 (METAL)

EXT-200-00

Extractor

TRL-101-40P

MCP, Trial, Proximal, Sz. 40 (METAL)

AWL-100-01

Awl, Starter

CSA-100-05

Instrument Base 05 - 40

CSA-000-01

Instrument Lid

CSA-100-06

Instrument Caddy 05 - 40

AWL-200-00

Alignment Awl

TRL-500-05

SMCP Trial Sz. 05

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

Finger

PyroCarbon implant MCP & SMCP Indications: The Ascension® MCP is indicated for use as a total joint replacement of index, long, ring, and small finger metacarpophalangeal (MCP) joints that exhibit symptoms of pain, limited motion, or inadequate bony alignment (i.e., subluxation/dislocation) secondary to articular destruction or degenerative disease related to rheumatoid arthritis, systemic lupus erythematosus, osteoarthritis, or post-traumatic arthritis where soft tissue reconstruction can provide adequate stabilization. Contraindications: Inadequate bone stock at the implantation site; active infection in the MCP joint; nonfunctioning and irreparable MCP musculotendinous system; physical interference with or by other prostheses during implantation or use; procedures requiring modification of the prosthesis; skin, bone, circulatory and/or neurological deficiency at the implantation site. Indications: The Ascension® Silicone MCP Finger Joint Prosthesis is intended for cementless replacement of the metacarpophalangeal (MCP) joint, where disabled by rheumotoid, degenerative, or traumatic arthritis. Contraindications: Active local or systemic infection ; Destruction of the metacarpal, phalanx, or phalanges or poor bone quality which prevents adequate fixation of the implant ; Loss of musculature, neuromuscular compromise, or vascular deficiency in the affected fingers ; Growing patients with open epiphyses ; Patient with high activity levels ; and patients unwilling or unable to comply with physician’s instructions.

Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Products mentioned in this document are CE class I, IIa and IIb 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”..

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

Finger

Pyrodisk™ CMC PyroCarbon stabilized spacer Implant Reference

Description

PYD-420-145-WW

PYD Comp. Sz. 145

PYD-420-165-WW

PYD Comp. Sz. 165

PYD-420-167-WW

PYD Comp. Sz. 167

PYD-420-168-WW

PYD Comp. Sz. 168

PYD-420-187-WW

PYD Comp. Sz. 187

PYD-420-189-WW

PYD Comp. Sz. 189

Instrument Reference

Description

AWL-420-00

Starter Awl

CSA-000-05

Instrument Lid

CSA-420-02

Instrument Base

GOU-420-00

Gouge

SHP-425-14

PyroDisk Shaper Sz. 14

SHP-425-16

PyroDisk Shaper Sz. 16

SHP-425-18

PyroDisk Shaper Sz. 18

TRL-420-145

PYD Trial Sz. 145

TRL-420-165

PYD Trial Sz. 165

TRL-420-167

PYD Trial Sz. 167

TRL-420-168

PYD Trial Sz. 168

TRL-420-187

PYD Trial Sz. 187

TRL-420-189

PYD Trial Sz. 189

Pyrodisk™ CMC pyrocarbon stabilized spacer Indications: The Ascension Pyrodisk is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thum with limited range of motion. Contraindications: Inadequate bone stock or soft tissue coverage ; previous open fracture or infection of the joint ; skeletal immaturity ; physical interference with or by other prostheses during implantation or use ; procedure requiring modification of the prosthesis ; skin, bone, circulatory and/or neurological deficiency at the implantation site. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. PyroDisk is a trademark of Integra LifeSciences Corporation or its subsidiaries. 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”.

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

Hand & Wrist

NuGrip™ CMC PyroCarbon hemi arthroplasty implant Implant

TMP-443-L

Size Template Sz. L

Reference

Description

TRL-443-10S

Metal NuGrip Trial Sz. 10S

NUG-443-10M

NuGrip Implant Size 10-M

TRL-443-10M

Metal NuGrip Trial Sz. 10M

NUG-443-10S

NuGrip Implant Size 10-S

TRL-443-20S

Metal NuGrip Trial Sz. 20S

NUG-443-20M

NuGrip Implant Size 20-M

TRL-443-20M

Metal NuGrip Trial Sz. 20M

NUG-443-20S

NuGrip Implant Size 20-S

TRL-443-30S

Metal NuGrip Trial Sz. 30S

NUG-443-30L

NuGrip Implant Size 30-L

TRL-443-30M

Metal NuGrip Trial Sz. 30M

NUG-443-30M

NuGrip Implant Size 30-M

TRL-443-30L

Metal NuGrip Trial Sz. 30L

NUG-443-30S

NuGrip Implant Size 30-S

TRL-443-40M

Metal NuGrip Trial Sz. 40M

NUG-443-40L

NuGrip Implant Size 40-L

TRL-443-40L

Metal NuGrip Trial Sz. 40L

NUG-443-40M

NuGrip Implant Size 40-M

RET-443-00

Hohman Retractor

CSA-443-02

Instrument Base

CSA-000-04

Instrument Lid

Instrument Reference

Description

BRH-442-40

Cutting Broach Size 40

CSA-443-05

Instrument Caddy

OSG-442-00

Vertical Cut Guide

CSA-443-06

Instrument Caddy Lid

EXT-100-01

Implant Extractor

BRH-442-10

Cutting Broach Size 10

ALG-100-00

Alignment Guide

BRH-442-20

Cutting Broach Size 20

EXT-200-00

Trial Extractor

BRH-442-30

Cutting Broach Size 30

AWL-100-01

Starter Awl

IMP-442-00

NuGrip Impactor

AWL-200-00

Alignment Awl

SHP-443-S

Finish Shaper Sz. S

Optional items

SHP-443-M

Finish Shaper Sz. M

CUT-443-L

Cannulated Spherical Cutter Sz. L

SHP-443-L

Finish Shaper Sz. L

CUT-443-M

Cannulated Spherical Cutter Sz. M

TMP-443-S

Size Template Sz. S

CUT-443-S

Cannulated Spherical Cutter Sz. S

TMP-443-M

Size Template Sz. M

NuGrip™ CMC pyrocarbon hemi arthroplasty implant Indications: The Ascension Nugrip is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. Contraindications: Inadequate bone stock or soft tissue coverage ; Previous open fracture or infection of the joint ; Skeletal immaturity ; Physical interference with or by other proetheses during implantation or use ; Procedures requiring modifications of the prosthesis ; Skin, bone, circulatory and/or neurological deficiency at the implantation site. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. NuGrip is a trademark of Integra LifeSciences Corporation or its subsidiaries. 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.

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

Finger

Hand & Wrist

PyroSphere™ - Pyrocarbon™ CMC spacer PCS Implants

Instruments

Reference

Description

Reference

Description

PCS-430-10-WW

PyroSphere size 10

CSA-430-01

Instrument Base

PCS-430-20-WW

PyroSphere size 20

CSA-000-03

Instrument lid

PCS-430-30-WW

PyroSphere size 30

TMP-400-10

Implant sizer instrument size 10

PCS-430-40-WW

PyroSphere size 40

TMP-400-20

Implant sizer instrument size 20

PCS-430-50-WW

PyroSphere size 50

TMP-400-30

Implant sizer instrument size 30

TMP-400-40

Implant sizer instrument size 40

TMP-400-50

Implant sizer instrument size 50

EXT-430-01

Implant Extractor

Pyrohemisphere™ set is needed to perform the surgery.

PyroSphere™ spacer PCS Indications: The Ascension PyroSphere is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion. The Ascension PyroSphere is also intended for use in the fourth/ fifth tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents: • decreased motion • arthritic changes and/or subluxation • unstable, stiff, or painful joints • degenerative joint disease of the midfoot • associated with gout or pseudogout Contraindications: • Inadequate bone stock or soft tissue coverage. • Previous open fracture or infection in the joint. • Skeletal immaturity. • Physical interference with or by other prostheses during implantation or use. • Procedures requiring modification of the prosthesis. • Skin, bone, circulatory and/or neurological deficiency at the implantation site. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. PyroSphere is a 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 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”.

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

Hand & Wrist

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

IntegraÂŽ Upper Extremity Nerve

Nerve

EndoRelease™ endoscopic cubital tunnel release system Instruments Reference

Description

092000

Sterilization tray

095160

Small locking obturator

095250

Large locking obturator

0211700

Obturator handle

095070

5 mm Spatula

095080

7 mm Spatula

095090

Small cannula (2.7 mm)

096020

Large cannula (4.0 mm)

Instruments Single Use Reference

Description

096000

Cubital Tunnel - Blade

096005

Cubital Tunnel - Set of 5 blades

EndoRelease™ endoscopic cubital tunnel release system Indications: The EndoRelease™ Endoscopic Cubital Tunnel Release System is intended for use in the endoscopic surgical treatment of cubital tunnel syndrome by releasing the fascia around the ulnar nerve. Contraindications: Repeat cubital tunnel release ; Distortion of anatomy ;Previous soft tissue injury at the surgical site. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. EndoRelease is a trademark of Integra LifeSciences Corporation. Products mentioned in this document are CE class I, IIa devices. Please contact Integra customer service should you need any additional information on devices classification. Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. • Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. • Warning: Applicable laws restrict these products to sale by or on the order of a physician. • Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use. All the 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”.

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

Integra LifeSciences Corporation. 4900 Charlemar Drive - Building A Cincinnati OH 45227, USA Phone: (609) 275-0500 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 00 Fax: +33(0)4 37 47 59 30

Nerve

Hand & Wrist

Safeguard™ mini-open carpal tunnel release system Instruments Reference

Description

080001

Guide

080005

5 knifes set

080003

SafeGuard Knife (1 unit)

Safeguard™ mini-open carpal tunnel release system Indications: The SafeGuard Mini C.T.R. System is indicated in the treatment of carpal tunnel syndrome in those patients who fail to respond to a full course of conservative treatment. Contraindications: Repeat carpal tunnel release ; Distortion of anatomy ; Neurologic defects ; Previous soft tissue injury at the surgical site. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. SafeGuard is a trademark of Integra LifeSciences Corporation. Products mentioned in this document are CE class I, IIa devices. Please contact Integra customer service should you need any additional information on devices classification. Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. • Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality. • Warning: Applicable laws restrict these products to sale by or on the order of a physician. • Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use. All the 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.

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

Hand & Wrist

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

IntegraÂŽ Upper Extremity Wrist

Wrist

Freedom Wrist System - total or hemi wrist replacement system Implants Reference

Description

348001E

Carpal plate, size 1

348002E

Carpal plate, size 2

348003E

Carpal plate, size 3

348291E

Carpal poly, size 1, standard

348292E

Carpal poly, size 1, +2 mm

348293E

Carpal poly, size 1, +4 mm

348294E

Carpal poly, size 2, standard

348295E

Carpal poly, size 2, +2 mm

348296E

Carpal poly, size 2, +4 mm

348297E

Carpal poly, size 3, standard

348298E

Carpal poly, size 3, +2 mm

348299E

Carpal poly, size 3, +4 mm

348315E

Carpal screw, 15 mm long

348317E

Carpal screw, 17.5 Mm long

348320E

Carpal screw, 20 mm long

348325E

Carpal screw, 25 mm long

348330E

Carpal screw, 30 mm long

348335E

Carpal screw, 35 mm long

348340E

Carpal screw, 40 mm long

348345E

Carpal screw, 45 mm long

348111E

Radial implant, size 1, left

348112E

Radial implant, size 1, right

348121E

Radial implant, size 2, left

348122E

Radial implant, size 2, right

348131E

Radial implant, size 3, left

348132E

Radial implant, size 3, right

Instruments

Reference

Description

348 089

.054" (1.4 mm) k-wire

348 091

2.5mm cannulated drill bit

348 092

3.5mm cannulated drill bit

348 093

4.0mm stop drill bit

348 041

Carpal plate trial, size 1

348 042

Carpal plate trial, size 2

348 043

Carpal plate trial, size 3

348 044

Carpal poly trial, size 1, standard

348 045

Carpal poly trial, size 1, +2 mm

348 046

Carpal poly trial, size 1, +4 mm

348 047

Carpal poly trial, size 2, standard

348 048

Carpal poly trial, size 2, +2 mm

348 049

Carpal poly trial, size 2, +4 mm

348 050

Carpal poly trial, size 3, standard

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

Wrist

348 051

Carpal poly trial, size 3, +2 mm

348 140

Radial template size 3

348 052

Carpal poly trial, size 3, +4 mm

348 141

Radial im guide rod

348 054

Carpal sizer

348 142

Radial feeler

348 055

Modular drill guide

348 143

Radial resection guide size 1

348 059

K-wire sleeve

348 144

Radial resection guide size 2

348 060

Carpal guide bar

348 145

Radial resection guide size 3

348 061

Carpal resection guide

348 146

Broach handle

348 063

Hamate feeler

348 154

Box punch, left

348 068

Carpal reamer size 1

348 156

Box punch, right

348 070

Carpal reamer size 2

348 160

Radial broach size 1 left

348 072

Carpal reamer size 3

348 163

Radial broach size 1 right

348 075

Carpal cement reamer

348 166

Radial broach size 2 left

348 081

Carpal plate impactor

348 169

Radial broach size 2 right

348 083

Carpal poly impactor

348 172

Radial broach size 3 left

348 088

Tissue protective sleeve

348 175

Radial broach size 3 right

348 090

K-wire depth gauge

348 178

Radial broach size 4 left

348 094

T15 star driver

348 181

Radial broach size 4 right

348 095

2.5Mm hex driver

348 184

Radial impactor

348 101

Radial trial, size 1, left

348 186

Radial trial remover

348 102

Radial trial, size 1, right

348 189

Radial drill guide, left

348 103

Radial trial, size 2, left

348 191

Radial drill guide, right

348 104

Radial trial, size 2, right

348 195

Anti-rotation pin

348 105

Radial trial, size 3, left

RM1011SO3

Ao handle

348 106

Radial trial, size 3, right

CONTAINER

348 137

Radial score guide

348280

Instrument case base

348 138

Radial template size 1

348281

Instrument case insert

348 139

Radial template size 2

CSA00014

Generic case lid – full din

Freedom Wrist System - total or hemi wrist replacement system Indications: The Integra Freedom Wrist Arthroplasty System, when used as a total wrist arthroplasty is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. When used as a hemiarthroplasty, the system is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Integra Freedom Wrist Arthroplasty System is intended for cemented or cementless use. Contraindications: Contraindications for the use of the Integra Freedom Wrist Arthroplasty System include any condition which would contraindicate the use of joint replacement in general, including: • Poor bone quality which may affect the stability of implants. • Severe tendon, neurological, or vascular deficiencies which could compromise the affected extremity. • Any concomitant disease which may compromise the function of the implants. • Infections; acute or chronic, local or systemic. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries.

Products mentioned in this document are CE class I, IIa and IIb 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” .

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

Wrist

Universal 2™ total wrist implant system Subject to available stock Implant Reference

Description

263100RT

Radial Implant, Extra Small, Right

263100LF

Radial Implant, Extra Small, Left

263200RT

Radial Implant, Small, Right

263200LF

Radial Implant, Small, Left

263300RT

Radial Implant, Medium, Right

2633001LF

Radial Implant, Medium, Left

263400RT

Radial Implant, Large, Right

263400LF

Radial Implant, Large, Left

261101

Carpal Implant, Extra Small

261201

Carpal Implant, Small

261301

Carpal Implant, Medium

261401

Carpal Implant, Large

262100

Carpal Poly Implant, Extra Small, Standard

262200

Carpal Poly Implant, Small, Standard

262300

Carpal Poly Implant, Medium, Standard

262400

Carpal Poly Implant, Large, Standard

262101

Carpal Poly Implant, Extra Small, +1

262201

Carpal Poly Implant, Small, +1

262301

Carpal Poly Implant, Medium, +1

262401

Carpal Poly Implant, Large, +1

262102

Carpal Poly Implant, Extra Small, +2

262202

Carpal Poly Implant, Small, +2

262302

Carpal Poly Implant, Medium, +2

262402

Carpal Poly Implant, Large, +2

NON STERILE SCREWS 264515

4.5mm Bone Screw, 15mm – non sterile

264520

4.5mm Bone Screw, 20mm – non sterile

264525

4.5mm Bone Screw, 25mm – non sterile

264530

4.5mm Bone Screw, 30mm – non sterile

264535

4.5mm Bone Screw, 35mm – non sterile

STERILE SCREWS

264515S

4.5mm Bone Screw, 15mm –sterile

264520S

4.5mm Bone Screw, 20mm –sterile

264525S

4.5mm Bone Screw, 25mm –sterile

264530S

4.5mm Bone Screw, 30mm –sterile

264535S

4.5mm Bone Screw, 35mm –sterile

Instrument Reference

Description

260515

Trial screw, 4.5Mm solid, cancellous 15mm

260520

Trial screw, 4.5Mm solid, cancellous 20mm

260525

Trial screw, 4.5Mm solid, cancellous 25mm

260530

Trial screw, 4.5Mm solid, cancellous 30mm

260535

Trial screw, 4.5Mm solid, cancellous 35mm

265100

Trial, carpal x-small

265200

Trial, carpal small

265300

Trial, carpal medium

265400

Trial, carpal large

266100

Trial, carpal poly, x-small

266101

Trial carpal poly, x-small +1

266102

Trial carpal poly, x-small +2

266200

Trial, carpal poly, small

266201

Trial, carpal poly, small +1

266202

Trial carpal poly, small +2

266300

Trial, carpal poly, medium

266301

Trial, carpal poly, medium +1

266302

Trial carpal poly, medium +2

266400

Trial, carpal poly, large

266401

Trial carpal poly, large +1

266402

Trial carpal poly, large +2

267100LF

Trial, radial x-small, left

267100RT

Trial, radial x-small, right

267200LF

Trial, radial small, left

267200RT

Trial, radial small, right

267300LF

Trial, radial medium, left

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

Wrist

267300RT

Trial, radial medium, right

268706

6mm counter sink

267400LT

Trial, radial large, left

268725

Shaft, hex driver 2.5Mm

267400RT

Trial, radial large, right

268232

Radial guide rod, 150mm

268100

Modular drill guide

268233

Radial guide rod, 200mm

268120

Guide plate extra small

260100

Sterilization tray

268121

Guide plate, small

SINGLE USE

268122

Guide plate, medium

268111

1.1mm k-wire 100mm

268123

Guide plate large

268114

1.4mm k-wire 150mm

268220

Bone awl

268125

Drill bit, 2.5mm, solid

268230LF

Radial cutting guide, left

211625

Drill bit, 2.5mm cannulated

268230RT

Radial cutting guide, right

268136

Drill bit, 3.5mm cannulated

268231

Radial guide bar

268145

Drill bit, 4.5mm, cannulated

268325

Carpal guide bar, minimal

268335

Carpal guide bar, standard

268340

Carpal cutting guide

268410LF

Broach, radial x-small, left

268410RT

Broach, radial x-small, right

268420LF

Broach, radial small, left

268420RT

Broach, radial small, right

268430LF

Broach, radial medium, left

268430RT

Broach, radial medium, right

268440LF

Broach, radial large, left

268440RT

Broach, radial large, right

268510

Broach handle

268610

T handle

268640

Carpal poly impactor

268650

Radial impactor

268660

Poly impactor

268700

Ao quick couple driver

Universal2™ total wrist implant system Indications: The Universal2™ Total Wrist System is indicated for use in patients suffering pain and/or loss of function due to: -Traumatic Arthritis -Osteoarthritis -Rheumatoid Arthritis -SLAC Wrist The Universal2™ Total Wrist may also be indicated for use in the revision of a failed implant, in younger patients with articular joint disease, or in difficult situations where clinical experience indicates that other reconstructive efforts are likely to achieve unsatisfactory results. Use should be limited to those conditions where preoperative exam indicates sufficient bone stock for the support of the implants. Contraindications: Contraindications for the use of the Universal2™ Total Wrist include any condition which would contraindicate the use of joint replacement in general, including: -Poor bone quality which may affect the stability of implants -Severe tendon, neurological, or vascular deficiencies which could compromise the affected extremity -Any concomitant disease which may compromise the function of the implants -Infections; acute or chronic, local or systemic. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Universal2 is a trademark of Integra LifeSciences Corporation. 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.

Integra LifeSciences Corporation 4900 Charlemar Drive - Building A Cincinnati - OH 45227 - USA Phone: (609) 275-0500 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 00 Fax: +33(0)4 37 47 59 30

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”.

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

Wrist

IntegraÂ® total wrist fusion system ITWFS Plates Reference

Description

303100S

Straight plate

303101S

Standard bend plate

303102S

Short bend plate

Screws

Reference

Description

303210CS

2.7mm cortical screw 10mm long

303212CS

2.7mm cortical screw 12mm long

303214CS

2.7mm cortical screw 14mm long

303216CS

2.7mm cortical screw 16mm long

303218CS

2.7mm cortical screw 18mm long

303220CS

2.7mm cortical screw 20mm long

303222CS

2.7mm cortical screw 22mm long

303224CS

2.7mm cortical screw 24mm long

303312CS

3.5mm cortical screw 12mm long

303314CS

3.5mm cortical screw 14mm long

303316CS

3.5mm cortical screw 16mm long

303318CS

3.5mm cortical screw 18mm long

303320CS

3.5mm cortical screw 20mm long

303322CS

3.5mm cortical screw 22mm long

303324CS

3.5mm cortical screw 24mm long

303326CS

3.5mm cortical screw 26mm long

303328CS

3.5mm cortical screw 28mm long

286210S

2.7mm surfix screw 10mm long and 2.7mm surfix washer

286212S

2.7mm surfix screw 12mm long and 2.7mm surfix washer

286214S

2.7mm surfix screw 14mm long and 2.7mm surfix washer

286216S

2.7mm surfix screw 16mm long and 2.7mm surfix washer

286218S

2.7mm surfix screw 18mm long and 2.7mm surfix washer

286220S

2.7mm surfix screw 20mm long and 2.7mm surfix washer

286222S

2.7mm surfix screw 22mm long and 2.7mm surfix washer

286224S

2.7mm surfix screw 24mm long and 2.7mm surfix washer

186200S

2.7mm surfix locking screw

286312S

3.5mm surfix screw 12mm long and 3.5mm surfix washer

286314S

3.5mm surfix screw 14mm long and 3.5mm surfix washer

286316S

3.5mm surfix screw 16mm long and 3.5mm surfix washer

286318S

3.5mm surfix screw 18mm long and 3.5mm surfix washer

286320S

3.5mm surfix screw 20mm long and 3.5mm surfix washer

286322S

3.5mm surfix screw 22mm long and 3.5mm surfix washer

286324S

3.5mm surfix screw 24mm long and 3.5mm surfix washer

286326S

3.5mm surfix screw 26mm long and 3.5mm surfix washer

286328S

3.5mm surfix screw 28mm long and 3.5mm surfix washer

186300S

3.5mm surfix locking screw

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

Wrist

Instruments Reference

Description

303400

2.0mm drill bit

303401

2.5mm drill bit

303402

2.7mm drill bit

303403

Double-ended drill guide for 2.0Mm drill bit

303404

Double-ended drill guide for 2.5Mm drill bit

303405

Threaded drill guide for 2.0Mm drill bit

303406

Threaded drill guide for 2.7Mm drill bit

303407

Depth gauge

303408

Self-retaining torx driver

303409

2.5mm self-retaining hex driver

303410

2.0mm self-retaining hex driver

303411

Plate bender - (2.7Mm hole)

303412

Plate bender - (3.5Mm hole)

303450

Straight plate trial

303451

Standard bend plate trial

303452

Short bend plate trial

600731

Screw forceps

303502

Instrument case top level - us/emea

303504

Instrument case lid - us/emea

Integra® total wrist fusion system ITWFS Indications: The INTEGRA Total Wrist Fusion System is indicated for use in patients with: - Post-traumatic arthritis of the joints of the wrist - Rheumatoid wrist deformities requiring restoration - Complex carpal instability - Post-septic arthritis of the wrist - Severe unremitting wrist pain related to motion - Brachial plexus nerve palsies - Tumor resection - Spastic deformities - Pain and/ or loss of function due to osteoarthritis - Revision of failed partial wrist fusions. Contraindications: Use of the product is contraindicated in the presence of any of the following: Severe tendon, neurological, or muscular deficiencies that would compromise implant function ; Infection; acute or chronic, local or systemic ; Any concomitant disease which may compromise the function of the implant ; Current highly active inflammatory disease of the wrist. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Products mentioned in this document are CE class IIb, IIa and 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 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”.

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

For Ascension Integra LifeSciences Corporation 4900 Charlemar Drive - Building A Cincinnati - OH 45227 - USA Phone: (609) 275-0500 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 00 Fax: +33(0)4 37 47 59 30

Newdeal (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 51 51 Fax: +33(0)4 37 47 51 52

Wrist

PyroCarbon lunate implant Implant Reference

Description

LUN-710-01-WW

PyroCarbon Lunate, Size 01

LUN-710-02-WW

PyroCarbon Lunate, Size 02

LUN-710-03-WW

PyroCarbon Lunate, Size 03

LUN-710-04-WW

PyroCarbon Lunate, Size 04

LUN-710-05-WW

PyroCarbon Lunate, Size 05

Instrument Reference

Description

CSA-710-02

Instrument Base

CSA-710-01

Instrument Lid

SZT-715-01S

Sizing Template, Size 01

SZT-715-02S

Sizing Template, Size 02

SZT-715-03S

Sizing Template, Size 03

SZT-7150-4S

Sizing Template, Size 04

SZT-7150-5S

Sizing Template, Size 05

TRL-715-01T

Lunate Trial, Sz 01

TRL-715-02T

Lunate Trial, Sz 02

TRL-715-03T

Lunate Trial, Sz 03

TRL-7150-4T

Lunate Trial, Sz 04

TRL-715-05T

Lunate Trial, Sz 05

PyroCarbon lunate implant Indications: The Ascension® Pyrocarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of: - Avascular necrosis (Kienboch’s disease); - Localized osteoarthritic changes; - Long-standing dislocaitons. Contraindications: Acute or chronic infection ; Radial scaphoid arthritis ; Gross carpal instability. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Products mentioned in this document are CE class I, IIa and IIb 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”.

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

Ascension Orthopedics, inc. 8700 Cameron road , Suite 100 Austin, Texas 78754 USA Phone: 512-836-5001 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 00 Fax: +33(0)4 37 47 59 30

Wrist

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

Wrist

First Choiceâ&#x201E;¢ Distal Radio Ulnar Joint system and Modular Ulnar Head system DRUJ & MUH Implant Reference

Description

MUH IMPLANTS MUH-600-45L-WW

MUH Stem Size S45L

MUH-600-55L-WW

MUH Stem Size S55L

MUH-600-65L-WW

MUH Stem Size S65L

MUH-600-65M-WW

MUH Stem Size S65M

MUH-600-55M-WW

MUH Stem Size S55M

MUH-600-45M-WW

MUH Stem Size S45M

MUH-600-45S-WW

MUH Stem Size S45S

MUH-600-H190-WW

MUH Head Size 190

MUH-600-H175-WW

MUH Head Size 175

MUH-600-65S-WW

MUH Stem Size S65S

MUH-600-55S-WW

MUH Stem Size S55S

MUH-600-H160-WW

MUH Head Size 160

DRUJ IMPLANTS DRUJ-610-1445-WW

14.5 mm head, 4.5 mm standard stem

DRUJ-610-1455-WW

14.5 mm head, 5.5 mm standard stem

DRUJ-610-1465-WW

14.5 mm head, 6.5 mm standard stem

DRUJ-610-1645-WW

16.0 mm head, 4.5 mm standard stem

DRUJ-610-1655-WW

16.0 mm head, 5.5 mm standard stem

DRUJ-610-1665-WW

16.0 mm head, 6.5 mm standard stem

DRUJ-610-1745-WW

17.5 mm head, 4.5 mm standard stem

DRUJ-610-1755-WW

17.5 mm head, 5.5 mm standard stem

DRUJ-610-1765-WW

17.5 mm head, 6.5 mm standard stem

DRUJ-610-1945-WW

19.0 mm head, 4.5 mm standard stem

DRUJ-610-1955-WW

19.0 mm head, 5.5 mm standard stem

DRUJ-610-1965-WW

19.0 mm head, 6.5 mm standard stem

Instrument

Reference

Description

CSA85000

Lid for container MUH + DRUJ

CSA60001

MUH insert

CSA61001

DRUJ insert

CSA61002

First Choice Tag

CSA85001

Container MUH + DRUJ

OSG-610-001

DRUJ Osteotomy Guide

TRL-610-H145-S45

DRUJ Trial Size 14.5-4.5

TRL-610-H145-S55

DRUJ Trial Size 14.5-5.5

TRL-610-H145-S65

DRUJ Trial Size 14.5-6.5

TRL-610-H160-S45

DRUJ Trial Size 16.0-4.5

TRL-610-H160-S55

DRUJ Trial Size 16.0-5.5

TRL-610-H160-S65

DRUJ Trial Size 16.0-6.5

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

Wrist

TRL-610-H175-S45

DRUJ Trial Size 17.5-4.5

TRL-610-H175-S55

DRUJ Trial Size 17.5-5.5

TRL-610-H175-S65

DRUJ Trial Size 17.5-6.5

TRL-610-H190-S45

DRUJ Trial Size 19.0-4.5

TRL-610-H190-S55

DRUJ Trial Size 19.0-5.5

TRL-610-H190-S65

DRUJ Trial Size 19.0-6.5

AWL-100-01

Starter Awl

BRH-600-S35

MUH Reamer Size 3.5, Starter

BRH-600-S45

MUH Reamer Size 4.5

BRH-600-S55

MUH Reamer Size 5.5

BRH-600-S65

MUH Reamer Size 6.5

EXT-200-00

Extractor

IMP-300-00

Implant Impactor

IMP-600-00

MUH Stem impactor

IMP-600-01

MUH Back Table Assy

OSG-600-00

MUH Resection Guide

OSG-600-01

MUH Ost. Guide

TRL-600-H160

MUH Head Trial Size 16

TRL-600-H175

MUH Head Trial Size 17.5

TRL-600-H190

MUH Head Trial Size 19.5

TRL-600-LNG

MUH Trial Adaptor LNG

TRL-600-MED

MUH Trial Adaptor MED

TRL-600-S45

MUH Stem Trial Size 4.5

TRL-600-S55

MUH Stem Trial Size 5.5

TRL-600-S65

MUH Stem Trial Size 6.5

First Choice™ DRUJ system and MUH system DRUJ indications: The First Choice’ Partial Ulnar Head implant is intended for partial replacement of the distal ulna for rheumatoid; degenerative, or post-traumatic arthritis presenting with pain and weakness localized to the distal radioulnar joint and not improved by conservative treatment. The First Choice Partial Ulnar Head implant is intended for press-fit use. DRUJ contraindications: Inadequate bone stock or soft tissue coverage• Previous open fracture or infection in the joint • Skeletal immaturity • Physical interference with or by other prostheses during implantation or use • Procedures requiring modification of the prosthesis • Skin, bone, circulatory and/or neurological deficiency at the implantation site MUH indications: The Ascension® First Choice® is intended for replacement of the distal radioulnar joint: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis presenting the following: • Pain and weakness of the wrist joint not improved by conservative treatment • Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes • Failed ulnar head resection

MUH contraindications: • Inadequate bone stock or soft tissue coverage • Previous open fracture or infection in the joint • Skeletal immaturity • Physical interference with or by other prostheses during implantation or use • Procedures requiring modification of the prosthesis • Skin, bone, circulatory and/or neurological deficiency at the implantation site Integra and Ascension are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. First Choice is a 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 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”.

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

Wrist

Spider™ - Mini Spider™ / limited wrist fusion system - Titanium Implants Reference

Instruments Description

Spider Implants Titanium

Reference

Description

600706

Depth Gauge

060005

Spider Limited Wrist Fusion Plate Titanium

600715

Spider Plate Holder

060006

Mini Spider Limited Wrist Fusion Plate Titanium

600716

Spider Rasp Cleaning Brush

062806

2.8mm Bone Screw, 6mm Titanium

600718

T-Handle

062808

2.8mm Bone Screw, 8mm Titanium

600719

Mini Spider Plate Holder

062810

2.8mm Bone Screw, 10mm Titanium

600722

1.5/2.0mm Drill Guide

062814

2.8mm Bone Screw, 14mm Titanium

600724

2.5mm Screw Driver Bit QC

062818

2.8mm Bone Screw, 18mm Titanium

600726

Screw Driver Holding Sleeve

600730

Screw Driver Handle QC

600731

Screw Holding Forceps

600740

Tap 4-1/2, 3.5mm dia.

065023

Sterilization case TI

600709

1.5mm Drill Bit

600704

2.0mm Drill Bit

600720

Std. Spider Rasp

600721

Mini Spider Rasp

Spider™ - Mini Spider™ / limited wrist fusion system - Titanium Indications: The limited wrist fusion plate is indicated for use in patients suffering pain and/or loss of function due to: - Osteoarthritis - Post-traumatic arthritis - Fractures - Revision of failed partial wrist fusions - Carpal Instability - Rheumatoid arthritis. Contraindications: Contraindications include any condition, that would contraindicate the use of plates and screws in general, including : Severe tendon, neurological or vascular deficiencies which may compromise the affected extremity; Any concomitant disease which may compromise the function of the plate ; Infection. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Spider and Mini Spider are trademarks of Integra LifeSciences Corporation in the United States and/or other countries. Products mentioned in this document are 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 add on medical devices and its relatives, unless specifically identified as “NOT CE MARKED”.

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

Hand & Wrist Wrist

Spider™ - Mini Spider™ / limited wrist fusion system - Stainless Steel Implants Reference

Instruments Reference

Description

Spider Implants Stainless Steel

Description

600706

Depth Gauge

070005

Spider Limited Wrist Fusion Plate Steel

600715

Spider Plate Holder

070006

Mini Spider Limited Wrist Fusion Plate Steel

600716

Spider Rasp Cleaning Brush

072408

2.4mm Bone Screw, 8mm Steel

600718

T-Handle

072410

2.4mm Bone Screw, 10mm Steel

600719

Mini Spider Plate Holder

072412

2.4mm Bone Screw, 12mm Steel

600722

1.5/2.0mm Drill Guide

072414

2.4mm Bone Screw, 14mm Steel

600724

2.5mm Screw Driver Bit QC

072810

2.8mm Bone Screw, 10mm Steel

600726

Screw Driver Holding Sleeve

072814

2.8mm Bone Screw, 14mm Steel

600730

Screw Driver Handle QC

072818

2.8mm Bone Screw, 18mm Steel

600731

Screw Holding Forceps

600740

Tap 4-1/2, 3.5mm dia.

075020

Sterilization Case SS

600709

1.5mm Drill Bit

600704

2.0mm Drill Bit

600720

Std. Spider Rasp

600721

Mini Spider Rasp

Spider™ - Mini Spider™ / limited wrist fusion system - Stainless Steel Indications: The limited wrist fusion plate is indicated for use in patients suffering pain and/or loss of function due to: - Osteoarthritis - Post-traumatic arthritis - Fractures - Revision of failed partial wrist fusions - Carpal Instability - Rheumatoid arthritis. Contraindications: Contraindications include any condition, that would contraindicate the use of plates and screws in general, including : Severe tendon, neurological or vascular deficiencies which may compromise the affected extremity; Any concomitant disease which may compromise the function of the plate ; Infection. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Spider and Mini Spider are trademarks of Integra LifeSciences Corporation 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”.

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

Wrist

WIFIX® Plate - Surfix® volar plate for distal radius Subject to available stock Implants Reference

Description

PDRA1

Volar plate for distal radius - size 1 length 44mm

PDRA2

Volar plate for distal radius - size 2 length 70mm

PDRA3

Volar plate for distal radius- size 3 length 96mm

V35012

Symetric profile screw and lock screw - dia 3.5 - L12mm

V35014

Symetric profile screw and lock screw - dia 3.5 - L14mm

V35016

Symetric profile screw and lock screw - dia 3.5 - L16mm

V35018

Symetric profile screw and lock screw - dia 3.5 - L18mm

V35020

Symetric profile screw and lock screw - dia 3.5 - L20mm

V35022

Symetric profile screw and lock screw - dia 3.5 - L22mm

V35024

Symetric profile screw and lock screw - dia 3.5 - L24mm

V35026

Symetric profile screw and lock screw - dia 3.5 - L26mm

Instruments Reference

Description

MA3501

Plate holder

MA3503

Plate bender

MA3504

Hexagonal screwdriver 2mm

MA3505

Lenght gauge

MA3506

Drill guide dia.2.7mm

MA3508

Drill dia.2.7mm L.125mm

FPDRA1

Trial plate PDRA1

FPDRA2

Trial plate PDRA2

FPDRA3

Trial plate PDRA3

SET335

Base of Wifix® instrument set

SET301

Wifix® Lid

WIFIX® Plate - Surfix® volar plate for distal radius Indications: Traumatology: • Articular or distal complex fractures of the radius • Anterior or posterior comminutive fractures with bone defect Reconstructive surgery: • Shortening osteotomy for Kienbock’s disease • Correction of distal radius malunion particulary anterior additional bone graft • Lunar radio-scapho arthrodesis • Radio-carpal arthrodesis Contraindications: • Acute infections • Absence of musculo-cutaneous covering • Bone deterioration preventing a good fixation of the screws in the bone Integra, WIFIX and Surfix are registered trademarks of Integra LifeSciences Corporation 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.

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

Newdeal (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 51 51 Fax: +33(0)4 37 47 51 52

Wrist

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

Hand &Notes Wrist

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

Hand & Wrist Notes

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

Integra® Upper Extremity Solutions Product Catalogue Finger, Nerve and Wrist 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, PyroSphere, Endorelease, Safeguard, Universal 2, First Choice, Spider, Mini-Spider and Katalyst are trademarks of Integra LifeSciences Corporation in the United State and / or other countries. WIFIX, Ascension, Surfix, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United Sates and/or other countries. ©2017 Integra LifeSciences Corporation. All rights reserved. Last revision date: 11/2017. 0827952-1-EN DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY.