CATALOG SOLUTII UMAR COT INTEGRA by ENLIFE SOLUTIONS by ENLIFE SOLUTIONS

IntegraÂŽ Shoulder & Elbow Solutions Product Catalog

Table of content

Elbow PyroCarbon modular radial head CMRH �� 6 Metal modular radial head MRH �� 8 Katalyst™ bipolar radial head system ��10 Shoulder Titan™ modular shoulder system TSS ��14 Titan™ modular shoulder system, TSS 2.5 ��18 Titan™ reverse shoulder system RSS �� 22 Shoulder retractors �� 28 Titan™ long stem - long stem & anatomic bodies for revision cases �� 30 Titan™ humeral resurfacing arthroplasty HRA �� 32

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

IntegraÂŽ Elbow

Elbow

PyroCarbon modular radial head CMRH Implant Reference

Description

Head CMRH-310-H20-WW

Carbon Radial Head size 20

CMRH-310-H22-WW

Carbon Radial Head size 22

CMRH-310-H24-WW

Carbon Radial Head size 24

Stem CMRH-310-S01L-WW

CMRH Stem Long Size 01

CMRH-310-S01S-WW

CMRH Stem Standard Size 01

CMRH-310-S02L-WW

CMRH Stem Long Size 02

CMRH-310-S02S-WW

CMRH Stem Standard Size 02

CMRH-310-S03L-WW

CMRH Stem Long Size 03

CMRH-310-S03S-WW

CMRH Stem Standard Size 03

CMRH-310-S04L-WW

CMRH Stem Long Size 04

CMRH-310-S04S-WW

CMRH Stem Standard Size 04

Instrument Reference

Description

AWL-100-01

Awl, Starter

BRH-300-20

Radial Head Broach Size 20

BRH-300-22

Radial Head Broach Size 22

BRH-300-24

Radial Head Broach Size 24

BRH-350-04

Broach, MRH, Sz. 04

EXT-350-00

Stem Holder, MRH

IMP-300-00

Implant Impactor

IMP-350-00

Impactor, Stem, MRH

IMP-350-01

Back Table Assembly Pad, MRH

OSG-350-01

Osteotomy Cut Guide, MRH

TRL-310-01

CMRH Stem Trial Size 01

TRL-310-02

CMRH Stem Trial Size 02

TRL-310-03

CMRH Stem Trial Size 03

TRL-310-04

CMRH Stem Trial Size 04

TRL-310-20L

CMRH Head Trial Size 20L

TRL-310-20S

CMRH Head Trial Size 20S

TRL-310-22L

CMRH Head Trial Size 22L

TRL-310-22S

CMRH Head Trial Size 22S

TRL-310-24L

CMRH Head Trial Size 24L

TRL-310-24S

CMRH Head Trial Size 24S

CONTAINER

CSA-000-01

Instrument Lid

CSA-310-01

Trial stem Caddy

CSA-350-02

Instrument Base

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

Elbow

PyroCarbon modular radial head CMRH Indications: • Replacement of the radial head for degenerative or posttraumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with - joint destruction or subluxation visible on x-ray, - resistance to conservative treatment; • Primary replacement after fracture of the radial head; • Symptomatic sequelae after radial head resection; • Revision following failed radial head arthroplasty. 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.

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 50 Fax: +33(0)4 37 47 59 30

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

Elbow

Metal modular radial head MRH Implant Reference

Description

Head MRH-350-20L-WW

Radial Head Sz 20 Long

MRH-350-20S-WW

Radial Head Sz 20 Standard

MRH-350-22L-WW

Radial Head Sz 22 Long

MRH-350-22S-WW

Radial Head Sz 22 Standard

MRH-350-24L-WW

Radial Head Sz 24 Long

MRH-350-24S-WW

Radial Head Sz 24 Standard

Stem MRH-350-01-WW

Stem Size 01

MRH-350-02-WW

Stem Size 02

MRH-350-03-WW

Stem Size 03

MRH-350-04-WW

Stem Size 04

Instrument Reference

Description

AWL-100-01

Awl, Starter

BRH-300-20

Radial Head Broach Size 20

BRH-300-22

Radial Head Broach Size 22

BRH-300-24

Radial Head Broach Size 24

BRH-350-04

Broach, MRH, Sz. 04

EXT-350-00

Stem Holder, MRH

IMP-300-00

Implant Impactor

IMP-350-00

Impactor, Stem, MRH

IMP-350-01

Back Table Assembly Pad, MRH

OSG-350-01

Osteotomy Cut Guide, MRH

TRL-351-20L

MRH Trial, Ti, Sz. 20L

TRL-351-20S

MRH Trial, Ti, Sz. 20S

TRL-351-22L

MRH Trial, Ti, Sz. 22L

TRL-351-22S

MRH Trial, Ti, Sz. 22S

TRL-351-24L

MRH Trial, Ti, Sz. 24L

TRL-351-24S

MRH Trial, Ti, Sz. 24S

CONTAINER

CSA-000-01

Instrument Lid

CSA-350-02

Instrument Base

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

Elbow

Metal modular radial head MRH Indications: • Replacement of the radial head for degenerative or posttraumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with - joint destruction or subluxation visible on x-ray, - resistance to conservative treatment; • Primary replacement after fracture of the radial head; • Symptomatic sequelae after radial head resection; • Revision following failed radial head arthroplasty. 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.

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

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

Elbow

Katalyst™ bipolar radial head system Implant Reference

Description

221418

18mm Head & Poly Assembly

221421

21mm Head & Poly Assembly

221424

24mm Head & Poly Assembly

221665

6.5mm Stem Assembly, 20mm length

221675

7.5mm Stem Assembly, 20mm Length

221800

Stem Replacement Set Screw

Instrument Reference

Description

224165

Stem Trial 6.5mm

224175

Stem Trial 7.5mm

224318

Head Trial 18mm

224321

Head Trial 21mm

224324

Head Trial 24mm

225365

6.5mm Broach

225375

7.5mm Broach

225400

Spacer 2mm

225405

First Spacer 1mm

225600

Cutting Template

225900

Head Sizing Template

226000

Starter Awl

600717

2.5mm Hex Driver

225205

Pliers

CONTAINER 221001

Sterilization Tray

Katalyst™ Bipolar Radial Head System - Bipolar Radial Head Prosthesis Indications: • Comminuted radial head fracture with or without associated elbow instability; • Comminuted radial head fracture with associated failure of the interosseous membrane; the Essex-Lopresti lesion ; • Primary osteoarthritis involoving the radiocapitellar joint or proximal radioulnar joint; • Revision of failed radial head implant. Contraindications: Inadequate bone and surrounding soft-tissues to accept and support the prosthesis • Infection; • Open physes in the radius, ulna and distal humerus; • Neurological, metabolic or other medical conditions that might compromise the bone, soft tissues or proprioception about the elbow joint; • Known sensitivities to the materials in the implant; • Avascular necrosis where bone stock has been rendered inadequate. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Katalyst 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

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 50 Fax: +33(0)4 37 47 59 30

Elbow

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

IntegraÂŽ Shoulder

Shoulder

Titanâ&#x201E;¢ modular shoulder system TSS Implant Reference

Description

Humeral Stem STEM-0920-025-06

Press Fit Stem, 6mm

STEM-0920-025-07

Press Fit Stem, 7mm

STEM-0920-025-08

Press Fit Stem, 8mm

STEM-0920-025-09

Press Fit Stem, 9mm

STEM-0920-025-10

Press Fit Stem, 10mm

STEM-0920-025-11

Press Fit Stem, 11mm

STEM-0920-025-12

Press Fit Stem, 12mm

STEM-0920-025-13

Press Fit Stem, 13mm

STEM-0920-025-14

Press Fit Stem, 14mm

STEM-0920-025-15

Press Fit Stem, 15mm

STEM-0920-025-16

Press Fit Stem, 16mm

STEM-0950-025-06

Cemented Stem, 6mm

STEM-0950-025-08

Cemented Stem, 8mm

STEM-0950-025-10

Cemented Stem, 10mm

Humeral Head - Concentric

STEM-0950-025-12

Cemented Stem, 12mm

MHH-0920-010-4216C

TSS Concentric Humeral Head 42x16mm

STEM-0950-025-14

Cemented Stem, 14mm

MHH-0920-010-4416C

TSS Concentric Humeral Head 44x16mm

MHH-0920-010-4419C

TSS Concentric Humeral Head 44x19mm

BOD-0920-020-08STD

TSS Primary Body, Size 8 Standard

MHH-0920-010-4614C

TSS Concentric Humeral Head 46x14mm

BOD-0920-020-10SML

TSS Primary Body, Size 10 Small

MHH-0920-010-4617C

TSS Concentric Humeral Head 46x17mm

BOD-0920-020-10STD

TSS Primary Body, Size 10 Standard

MHH-0920-010-4620C

TSS Concentric Humeral Head 46x20mm

BOD-0920-020-10LRG

TSS Primary Body, Size 10 Large

Humeral Body - Primary

MHH-0920-010-4815C

TSS Concentric Humeral Head 48x15mm

BOD-0920-020-12STD TSS Primary Body, Size 12 Standard

MHH-0920-010-4818C

TSS Concentric Humeral Head 48x18mm

BOD-0920-020-14SML

TSS Primary Body, Size 14 Small

MHH-0920-010-4821C

TSS Concentric Humeral Head 48x21mm

BOD-0920-020-14STD

TSS Primary Body, Size 14 Standard

MHH-0920-010-5019C

TSS Concentric Humeral Head 50x19mm

BOD-0920-020-14LRG

TSS Primary Body, Size 14 Large

MHH-0920-010-5022C

TSS Concentric Humeral Head 50x22mm

MHH-0920-010-5220C

TSS Concentric Humeral Head 52x20mm

Humeral Body - Fracture BOD-0950-020-08SML

TSS Fracture Body, Size 8 Small

Humeral Head - Eccentric

BOD-0950-020-08STD

TSS Fracture Body, Size 8 Standard

MHH-0920-010-3814E

TSS Eccentric Humeral Head 38x14mm

BOD-0950-020-08LRG

TSS Fracture Body, Size 8 Large

MHH-0920-010-4015E

TSS Eccentric Humeral Head 40x15mm

MHH-0920-010-4216E

TSS Eccentric Humeral Head 42x16mm

MHH-0920-010-4416E

TSS Eccentric Humeral Head 44x16mm

Body Screw BSW-0920-021-01

TSS Body Screw

MHH-0920-010-4419E TSS Eccentric Humeral Head 44x19mm

Glenoid - Pegged GLN-0920-030-00P

TSS Pegged Glenoid XS

MHH-0920-010-4614E

TSS Eccentric Humeral Head 46x14mm

GLN-0920-030-01P

TSS Pegged Glenoid S

MHH-0920-010-4617E

TSS Eccentric Humeral Head 46x17mm

GLN-0920-030-02P

TSS Pegged Glenoid M

MHH-0920-010-4620E

TSS Eccentric Humeral Head 46x20mm

GLN-0920-030-03P

TSS Pegged Glenoid L

MHH-0920-010-4815E

TSS Eccentric Humeral Head 48x15mm

MHH-0920-010-4818E

TSS Eccentric Humeral Head 48x18mm

GLN-0920-030-00K

TSS Keeled Glenoid XS

MHH-0920-010-4821E

TSS Eccentric Humeral Head 48x21mm

GLN-0920-030-01K

TSS Keeled Glenoid S

MHH-0920-010-5019E

TSS Eccentric Humeral Head 50x19mm

GLN-0920-030-02K

TSS Keeled Glenoid M

MHH-0920-010-5022E

TSS Eccentric Humeral Head 50x22mm

GLN-0920-030-03K

TSS Keeled Glenoid L

MHH-0920-010-5220E

TSS Eccentric Humeral Head 52x20mm

Glenosphere - Keeled

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

Shoulder

Instrument Reference

Humeral Tray 1 - Insert Description

Humeral Tray 1 - Base

AWL-0920-042-001

Starter Awl

GAU-0920-058-001

Head Cutting Depth Gauge

ADT-0920-065-001

Taper Adapter

HSG-0920-041-001

Head Sizing Gauge 38-46

HDL-0920-043-001

Stem Trial Handle

HSG-0920-041-002

Head Sizing Gauge 48-52

INS-0920-046-001

Humeral Trial Inserter/ Extractor

NR135004-J-004

T-Handle w/ Lg AO

INS-0950-046-001

Humeral Fracture Trial Inserter/Extractor

PIN-0920-051-001

Fixation pin

RMR-0920-050-001

Calcar Planer, Small

PUL-0920-087-01

Pin Puller

RMR-0920-050-002

Calcar Planer, Large

ROD-0920-040-002

Head Cutting Template Handle

SCR-0920-066-001

Taper Adapter Shaft

SET189-A001

Head Cutting Guide

TDT-0920-044-001

Taper Disassembly Tool

SET189-D007

Version Rod

TRL-0920-020-08STD

Body Trial, 8 Standard

TMP-0920-040-001L

Head Cutting Template, Left

TRL-0920-020-10LRG

Body Trial, 10 Large

TMP-0920-040-001R

Head Cutting Template, Right

TRL-0920-020-10SML

Body Trial, 10 Small

Humeral Tray 1 - Container

TRL-0920-020-10STD

Body Trial, 10 Standard

CSA-000-14

Generic Case Lid - Full DIN

TRL-0920-020-12STD

Body Trial, 12 Standard

CSA-0920-15

TSS Humeral Inst Set 1 Case Base

TRL-0920-020-14LRG

Body Trial, 14 Large

CSA-0920-16

TSS Humeral Inst Set 1 Insert Tray

TRL-0920-020-14SML

Body Trial, 14 Small

CSA-0920-17

TSS Humeral Inst Set 1 Prox Trial Caddy Base

TRL-0920-020-14STD

Body Trial, 14 Standard

CSA-0920-18

TSS Humeral Inst Set 1 Prox Trial Caddy Lid

TRL-0950-020-08LRG

Fracture Body Trial, 8 Large

CSA-0920-19

TSS Humeral Inst Set 1 Tray Taper Adap Caddy Base

TRL-0950-020-08SML

Fracture Body Trial, 8 Small

CSA-0920-20

TSS Humeral Inst Set 1 Tray Taper Adap Caddy Lid

TRL-0950-020-08STD

Fracture Body Trial, 8 Standard

TRL-0920-025-06

Humeral Stem Trial, 6mm

TRL-0920-025-07

Humeral Stem Trial, 7mm

TRL-0920-025-08

Humeral Stem Trial, 8mm

TRL-0920-025-09

Humeral Stem Trial, 9mm

TRL-0920-025-10

Humeral Stem Trial, 10mm

TRL-0920-025-11

Humeral Stem Trial, 11mm

TRL-0920-025-12

Humeral Stem Trial, 12mm

TRL-0920-025-13

Humeral Stem Trial, 13mm

TRL-0920-025-14

Humeral Stem Trial, 14mm

TRL-0920-025-15

Humeral Stem Trial, 15mm

TRL-0920-025-16

Humeral Stem Trial, 16mm

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

Shoulder

HSP-0920-070-008

Head Sizing Plate, 52mm

TRL-0920-010-3814E

Head Trial, Ecc, Size 38x14mm

TRL-0920-010-4015E

Head Trial, Ecc, Size 40x15mm

TRL-0920-010-4216C

Head Trial, Cen, Size 42x16mm

TRL-0920-010-4216E

Head Trial, Ecc, Size 42x16mm

TRL-0920-010-4416C

Head Trial, Cen, Size 44x16mm

TRL-0920-010-4416E

Head Trial, Ecc, Size 44x16mm

TRL-0920-010-4419C

Head Trial, Cen, Size 44x19mm

TRL-0920-010-4419E

Head Trial, Ecc, Size 44x19mm

TRL-0920-010-4614C

Head Trial, Cen, Size 46x14mm

TRL-0920-010-4614E

Head Trial, Ecc, Size 46x14mm

TRL-0920-010-4617C

Head Trial, Cen, Size 46x17mm

TRL-0920-010-4617E

Head Trial, Ecc, Size 46x17mm

Stem Impactor

TRL-0920-010-4620C

Head Trial, Cen, Size 46x20mm

IMP-0920-079-501

TSS Head Impactor

TRL-0920-010-4620E

Head Trial, Ecc, Size 46x20mm

INS-0920-045-001

Humeral Implant Inserter/ Extractor

TRL-0920-010-4815C

Head Trial, Cen, Size 48x15mm

INS-0920-071-LRG

Head Impaction Stand Insert, Large

TRL-0920-010-4815E

Head Trial, Ecc, Size 48x15mm

INS-0920-071-SML

Head Impaction Stand Insert, Small

TRL-0920-010-4818C

Head Trial, Cen, Size 48x18mm

INS-0920-071-STD

Head Impaction Stand Insert, Std

TRL-0920-010-4818E

Head Trial, Ecc, Size 48x18mm

INS-0950-045-001

Humeral Fracture Implant Inserter/Extractor

TRL-0920-010-4821C

Head Trial, Cen, Size 48x21mm

MAL-0920-085-01

Slotted Mallet

TRL-0920-010-4821E

Head Trial, Ecc, Size 48x21mm

SCR-0920-060-001

1/8 Hexdriver

TRL-0920-010-5019C

Head Trial, Cen, Size 50x19mm

SEP-0920-068-001

Body Separator

TRL-0920-010-5019E

Head Trial, Ecc, Size 50x19mm

SET188-A001

Head Extractor

TRL-0920-010-5022C

Head Trial, Cen, Size 50x22mm

SIS-0920-054-001

Stem Impaction Stand

TRL-0920-010-5022E

Head Trial, Ecc, Size 50x22mm

STD-0920-071-001

Head Impaction Stand, Base Assembly

TRL-0920-010-5220C

Head Trial, Cen, Size 52x20mm

TRQ-0920-086-01

Torque Limiter

TRL-0920-010-5220E

Head Trial, Ecc, Size 52x20mm

Instrument Reference

Description

Humeral Tray 2 - Base IMP-0920-055-001

Humeral Tray 2 - Container CSA-000-14

Generic Case Lid - Full DIN

CSA-0920-21

TSS Humeral Inst Set Case Base

CSA-0920-22

TSS Humeral Inst Set Insert Tray

Humeral Tray 2 - Insert

G107992_B

Driver Handle w/ Sm AO

HSP-0920-070-001E

Head Sizing Plate, 38mm

HSP-0920-070-002E

Head Sizing Plate, 40mm

HSP-0920-070-003

Head Sizing Plate, 42mm

HSP-0920-070-004

Head Sizing Plate, 44mm

HSP-0920-070-005

Head Sizing Plate, 46mm

HSP-0920-070-006

Head Sizing Plate, 48mm

HSP-0920-070-007

Head Sizing Plate, 50mm

Instrument Reference

Description

Glenoid Tray - Base HDL-0922-082-01

Glenoid Drill Shaft

IMP-0920-064-001

Glenoid Impactor

PUN-0920-062-001

Glenoid Keel Punch, XSm/Sm

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

Shoulder

PUN-0920-062-002

Glenoid Keel Punch, Med/Lg

PEG-0922-074-02

TSS Anti-rotation Peg

PUN-0920-072-001

Glenoid Peg Punch, XSm/Sm

RMR-0920-057-000

Glenoid Reamer, Extra Small

PUN-0920-072-002

Glenoid Peg Punch, Med/Lg

RMR-0920-057-001

Glenoid Reamer, Small

RMR-0920-057-002

Glenoid Reamer, Medium

RMR-0920-057-003

Glenoid Reamer, Large

SZR-0920-052-000

Glenoid Sizer, Extra Small

SZR-0920-052-001

Glenoid Sizer, Small

SZR-0920-052-002

Glenoid Sizer, Medium

SZR-0920-052-003

Glenoid Sizer, Large

TRL-0920-030-00K

Glenoid, Keel Trial, Extra Small

TRL-0920-030-00P

Glenoid, Peg Trial, Extra Small

TRL-0920-030-01K

Glenoid, Keel Trial, Small

TRL-0920-030-01P

Glenoid, Peg Trial, Small

TRL-0920-030-02K

Glenoid, Keel Trial, Medium

TRL-0920-030-02P

Glenoid, Peg Trial, Medium

TRL-0920-030-03K

Glenoid, Keel Trial, Large

TRL-0920-030-03P

Glenoid, Peg Trial, Large

Glenoid Tray - Insert BSH-0920-048-001

Pin Bushing

BSH-0920-048-002

Center Starter Drill Bushing

DRG-0920-049-001

Center Glenoid Drill Guide, X-Sm/Sm

DRG-0920-049-002

Center Glenoid Drill Guide, Med/Lg

DRG-0922-067-01

Glenoid Drill Guide, X-Sm/Sm

DRG-0922-067-02

Glenoid Drill Guide, Med/Lg

DRL-0920-047-001

Cannulated Center Starter Drill

DRL-0920-047-002

Cannulated Peg Drill

DRL-0920-056-001

Solid Center Starter Drill

DRL-0922-080-01

TSS Glenoid Solid Peg Drill

GDW-0920-061-501

2.0mm x 150mm Guide Pin

HDL-0920-075-001

Anti-rotation Peg Holder

HDR-0920-063-001

Glenoid Holder

Glenoid Tray - Container CSA-000-14

Generic Case Lid - Full DIN

CSA-0920-23

TSS Glenoid Inst Set Case Base

CSA-0920-24

TSS Glenoid Inst Set Insert Tray

CSA-0920-25

TSS Glenoid Inst Set Caddy Base

CSA-0920-26

TSS Glenoid Inst Set Caddy Lid

Titan™ modular shoulder system Indications: Total Shoulder Arthroplasty or Hemiarthroplasty is indicated for: • Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. • Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory. • Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component). Total Shoulder Arthroplasty or Hemiarthroplasty is indicated for: • Ununited humeral head fractures. • Avascular necrosis of the humeral head. • Rotator cuff arthropathy. • Deformity and/or limited motion. The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.

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

Contraindications: The following conditions are contraindications for reverse total shoulder arthroplasty: • Active local or systemic infection. • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components. • Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid. The following condition is a contraindication for total shoulder arthroplasty: • Absent, irreparable or nonfunctional rotator cuff or other essential muscles. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Titan 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 lll 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

Shoulder

Titanâ&#x201E;¢ modular shoulder system, TSS 2.5 Implant Reference

Description

Humeral Stem STEM-0920-025-06

Press Fit Stem, 6mm

STEM-0920-025-07

Press Fit Stem, 7mm

STEM-0920-025-08

Press Fit Stem, 8mm

STEM-0920-025-09

Press Fit Stem, 9mm

STEM-0920-025-10

Press Fit Stem, 10mm

STEM-0920-025-11

Press Fit Stem, 11mm

STEM-0920-025-12

Press Fit Stem, 12mm

STEM-0920-025-13

Press Fit Stem, 13mm

STEM-0920-025-14

Press Fit Stem, 14mm

STEM-0920-025-15

Press Fit Stem, 15mm

STEM-0920-025-16

Press Fit Stem, 16mm

STEM-0950-025-06

Cemented Stem, 6mm

STEM-0950-025-08

Cemented Stem, 8mm

STEM-0950-025-10

Cemented Stem, 10mm

Humeral Head - Concentric

STEM-0950-025-12

Cemented Stem, 12mm

MHH-0923-010-4216C

TSS CoCr Concentric Head, 2.5 42x16mm

STEM-0950-025-14

Cemented Stem, 14mm

MHH-0923-010-4416C

TSS CoCr Concentric Head, 2.5 44x16mm

MHH-0923-010-4419C

TSS CoCr Concentric Head, 2.5 44x19mm

BOD-0923-020-08STD

TSS Primary Proximal Body, 2.5 08STD

MHH-0923-010-4614C

TSS CoCr Concentric Head, 2.5 46x14mm

BOD-0923-020-10LRG

TSS Primary Proximal Body, 2.5 10LRG

MHH-0923-010-4617C

TSS CoCr Concentric Head, 2.5 46x17mm

BOD-0923-020-10SML

TSS Primary Proximal Body, 2.5 10SML

MHH-0923-010-4620C

TSS CoCr Concentric Head, 2.5 46x20mm

BOD-0923-020-10STD

TSS Primary Proximal Body, 2.5 10STD

MHH-0923-010-4815C

TSS CoCr Concentric Head, 2.5 48x15mm

BOD-0923-020-12STD

TSS Primary Proximal Body, 2.5 12STD

MHH-0923-010-4818C

TSS CoCr Concentric Head, 2.5 48x18mm

BOD-0923-020-14LRG

TSS Primary Proximal Body, 2.5 14LRG

MHH-0923-010-4821C

TSS CoCr Concentric Head, 2.5 48x21mm

BOD-0923-020-14SML

TSS Primary Proximal Body, 2.5 14SML

MHH-0923-010-5019C

TSS CoCr Concentric Head, 2.5 50x19mm

BOD-0923-020-14STD

TSS Primary Proximal Body, 2.5 14STD

MHH-0923-010-5022C

TSS CoCr Concentric Head, 2.5 50x22mm

MHH-0923-010-5220C

TSS CoCr Concentric Head, 2.5 52x20mm

Humeral Body - Primary

Humeral Body - Fracture BOD-0923-021-08LRG

TSS Fracture Proximal Body, 2.5 08LRG

Humeral Head - Eccentric

BOD-0923-021-08STD

TSS Fracture Proximal Body, 2.5 08STD

MHH-0923-010-3814E

TSS CoCr Eccentric Head, 2.5 38x14mm

BOD-0923-021-08SML

TSS Fracture Proximal Body, 2.5 08SML

MHH-0923-010-4015E

TSS CoCr Eccentric Head, 2.5 40x15mm

MHH-0923-010-4216E

TSS CoCr Eccentric Head, 2.5 42x16mm

MHH-0923-010-4416E

TSS CoCr Eccentric Head, 2.5 44x16mm

MHH-0923-010-4419E

TSS CoCr Eccentric Head, 2.5 44x19mm

Body Screw BSW-0920-021-01

TSS Body Screw

Glenoid - Pegged GLN-0920-030-00P

TSS Pegged Glenoid XS

MHH-0923-010-4614E

TSS CoCr Eccentric Head, 2.5 46x14mm

GLN-0920-030-01P

TSS Pegged Glenoid S

MHH-0923-010-4617E

TSS CoCr Eccentric Head, 2.5 46x17mm

GLN-0920-030-02P

TSS Pegged Glenoid M

MHH-0923-010-4620E

TSS CoCr Eccentric Head, 2.5 46x20mm

GLN-0920-030-03P

TSS Pegged Glenoid L

MHH-0923-010-4815E

TSS CoCr Eccentric Head, 2.5 48x15mm

MHH-0923-010-4818E

TSS CoCr Eccentric Head, 2.5 48x18mm

GLN-0920-030-00K

TSS Keeled Glenoid XS

MHH-0923-010-4821E

TSS CoCr Eccentric Head, 2.5 48x21mm

GLN-0920-030-01K

TSS Keeled Glenoid S

MHH-0923-010-5019E

TSS CoCr Eccentric Head, 2.5 50x19mm

GLN-0920-030-02K

TSS Keeled Glenoid M

MHH-0923-010-5022E

TSS CoCr Eccentric Head, 2.5 50x22mm

GLN-0920-030-03K

TSS Keeled Glenoid L

MHH-0923-010-5220E

TSS CoCr Eccentric Head, 2.5 52x20mm

Glenoid - Keeled

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

Shoulder

Instrument Reference

Humeral Tray 1 - Insert Description

Humeral Tray 1 - Base

AWL-0920-042-001

Starter Awl

G107992_B

Driver Handle w/ Sm AO

ADT-0923-065-001

TSS Taper Adapter, 2.5

GAU-0920-058-001

Head Cutting Depth Gauge

CVR-0920-076L

Trial Osteotomy Cover, Large

HSG-0920-041-001

Head Sizing Gauge 38-46

CVR-0920-076S

Trial Osteotomy Cover, Small

HSG-0920-041-002

Head Sizing Gauge 48-52

CVR-0920-077L

Canal Osteotomy Cover, Large

IMP-0920-055-001

Stem Impactor

CVR-0920-077S

Canal Osteotomy Cover, Small

MAL-0920-085-01

Slotted Mallet

HDL-0920-043-001

Stem Trial Handle

NR135004-J-004

T-Handle w/ Lg AO or Quick Connect Ratchet

HDS-0920-069-001

Depth Stop

PIN-0920-051-001

Fixation Pin

INS-0923-046-001

TSS Trial Inserter/Extractor, 2.5

PUL-0920-087-01

Pin Puller

RMR-0923-050-002

TSS Trial Calcar Planner, 2.5

ROD-0923-040-001

TSS Head Cutting Template Rod, 2.5

TRL-0920-020-08STD

Body Trial, 8 Standard

SCR-0920-060-001

1/8 Hexdriver

TRL-0920-020-10LRG

Body Trial, 10 Large

SET189-A001

Head Cutting Guide

TRL-0920-020-10SML

Body Trial, 10 Small

SET189-D007

Version Rod

TRL-0920-020-10STD

Body Trial, 10 Standard

TMP-0920-040-001L

Head Cutting Template, Left

TRL-0920-020-12STD

Body Trial, 12 Standard

TMP-0920-040-001R

Head Cutting Template, Right

TRL-0920-020-14LRG

Body Trial, 14 Large

TRQ-0920-086-01

Torque Limiter

TRL-0920-020-14SML

Body Trial, 14 Small

Humeral Tray 1 - Container

TRL-0920-020-14STD

Body Trial, 14 Standard

CSA-000-14

Generic Case Lid - Full DIN

TRL-0923-021-08LRG

TSS Fracture Body Trial LRG, 2.5

CSA-0923-01

TSS Humeral Inst Tray - Base Assembly

TRL-0923-021-08SML

TSS Fracture Body Trial SML, 2.5

CSA-0923-02

TSS Humeral Inst Tray - Tray Assembly

TRL-0923-021-08STD

TSS Fracture Body Trial STD, 2.5

CSA-0923-03

TSS Humeral Inst Tray - Body Trial Caddy

TRL-0920-025-06

Humeral Stem Trial, 6mm

CSA-0923-04

TSS Humeral Inst Tray - Body Trial Caddy Lid

TRL-0920-025-07

Humeral Stem Trial, 7mm

TRL-0920-025-08

Humeral Stem Trial, 8mm

TRL-0920-025-09

Humeral Stem Trial, 9mm

TRL-0920-025-10

Humeral Stem Trial, 10mm

TRL-0920-025-11

Humeral Stem Trial, 11mm

TRL-0920-025-12

Humeral Stem Trial, 12mm

TRL-0920-025-13

Humeral Stem Trial, 13mm

TRL-0920-025-14

Humeral Stem Trial, 14mm

TRL-0920-025-15

Humeral Stem Trial, 15mm

TRL-0920-025-16

Humeral Stem Trial, 16mm

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

Shoulder

Instrument Reference

Description

Humeral Tray 2 - Base INS-0920-071-LRG

Head Impaction Stand Insert, Large

INS-0920-071-SML

Head Impaction Stand Insert, Small

INS-0920-071-STD

Head Impaction Stand Insert, Std.

INS-0923-045-001

TSS Implant Inserter/Extractor, 2.5

RMR-0923-050-001

TSS Implants Calcar Planner, 2.5

SEP-0920-068-001

Body Separator

SET188-A001

Head Extractor

SIS-0920-054-001

Stem Impaction Stand

STD-0920-071-001

Head Impaction Stand, Base Assembly

TRL-0923-010-4216E

Head Trial, Ecc, 2.5, Size 42x16mm

TRL-0923-010-4416C

Head Trial, Cen, 2.5, Size 44x16mm

TRL-0923-010-4416E

Head Trial, Ecc, 2.5, Size 44x16mm

TRL-0923-010-4419C

Head Trial, Cen, 2.5, Size 44x19mm

TRL-0923-010-4419E

Head Trial, Ecc, 2.5, Size 44x19mm

TRL-0923-010-4614C

Head Trial, Cen, 2.5, Size 46x14mm

TRL-0923-010-4614E

Head Trial, Ecc, 2.5, Size 46x14mm

TRL-0923-010-4617C

Head Trial, Cen, 2.5, Size 46x17mm

TRL-0923-010-4617E

Head Trial, Ecc, 2.5, Size 46x17mm

TRL-0923-010-4620C

Head Trial, Cen, 2.5, Size 46x20mm

TRL-0923-010-4620E

Head Trial, Ecc, 2.5, Size 46x20mm

TRL-0923-010-4815C

Head Trial, Cen, 2.5, Size 48x15mm

TRL-0923-010-4815E

Head Trial, Ecc, 2.5, Size 48x15mm

TRL-0923-010-4818C

Head Trial, Cen, 2.5, Size 48x18mm

TRL-0923-010-4818E

Head Trial, Ecc, 2.5, Size 48x18mm

TRL-0923-010-4821C

Head Trial, Cen, 2.5, Size 48x21mm

TRL-0923-010-4821E

Head Trial, Ecc, 2.5, Size 48x21mm

TRL-0923-010-5019C

Head Trial, Cen, 2.5, Size 50x19mm

TRL-0923-010-5019E

Head Trial, Ecc, 2.5, Size 50x19mm

TRL-0923-010-5022C

Head Trial, Cen, 2.5, Size 50x22mm

TRL-0923-010-5022E

Head Trial, Ecc, 2.5, Size 50x22mm

TRL-0923-010-5220C

Head Trial, Cen, 2.5, Size 52x20mm

TRL-0923-010-5220E

Head Trial, Ecc, 2.5, Size 52x20mm

Humeral Tray 2 - Container CSA-000-14

Generic Case Lid - Full DIN

CSA-0923-05

TSS Humeral Inst Tray 2 - Base Assembly

CSA-0923-06

TSS Humeral Inst Tray 2 - Tray Assembly

Humeral Tray 2 - Insert

HSP-0923-070-001E

TSS Head Sizing Plates 38-40, 2.5 - 38E

HSP-0923-070-002E

TSS Head Sizing Plates 38-40, 2.5 - 40E

HSP-0923-070-003

TSS Head Sizing Plates 42-52, 2.5 - 42

HSP-0923-070-004

TSS Head Sizing Plates 42-52, 2.5 - 44

HSP-0923-070-005

TSS Head Sizing Plates 42-52, 2.5 - 46

HSP-0923-070-006

TSS Head Sizing Plates 42-52, 2.5 - 48

Instrument

HSP-0923-070-007

TSS Head Sizing Plates 42-52, 2.5 - 50

Reference

HSP-0923-070-008

TSS Head Sizing Plates 42-52, 2.5 - 52

Glenoid Tray - Base

IMP-0920-079-501

TSS Head Impactor

HDL-0922-082-01

Glenoid Drill Shaft

TDT-0920-044-001

Taper Disassembly Tool

IMP-0920-064-001

Glenoid Impactor

TRL-0923-010-3814E

Head Trial, Ecc, 2.5, Size 38x14mm

PRS-0923-073-001

Pressurizer XSm/Sm

TRL-0923-010-4015E

Head Trial, Ecc, 2.5, Size 40x15mm

PRS-0923-073-002

Pressurizer Med/Lg

TRL-0923-010-4216C

Head Trial, Cen, 2.5, Size 42x16mm

PUN-0920-062-001

Glenoid Keel Punch, XSm/Sm

Description

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

Shoulder

PUN-0920-062-002

Glenoid Keel Punch, Med/Lg

RMR-0920-057-002

Glenoid Reamer, Medium

PUN-0920-072-001

Glenoid Peg Punch, XSm/Sm

RMR-0920-057-003

Glenoid Reamer, Large

PUN-0920-072-002

Glenoid Peg Punch, Med/Lg

RMR-0920-059-000

Glenoid Five Flute Reamer, XS

RMR-0920-059-001

Glenoid Five Flute Reamer, S

RMR-0920-059-002

Glenoid Five Flute Reamer, M

RMR-0920-059-003

Glenoid Five Flute Reamer, L

SZR-0920-052-000

Glenoid Sizer, Extra Small

SZR-0920-052-001

Glenoid Sizer, Small

SZR-0920-052-002

Glenoid Sizer, Medium

SZR-0920-052-003

Glenoid Sizer, Large

TRL-0920-030-00K

Glenoid, Keel Trial, Extra Small

TRL-0920-030-00P

Glenoid, Peg Trial, Extra Small

TRL-0920-030-01K

Glenoid, Keel Trial, Small

TRL-0920-030-01P

Glenoid, Peg Trial, Small

TRL-0920-030-02K

Glenoid, Keel Trial, Medium

TRL-0920-030-02P

Glenoid, Peg Trial, Medium

TRL-0920-030-03K

Glenoid, Keel Trial, Large

TRL-0920-030-03P

Glenoid, Peg Trial, Large

Glenoid Tray - Insert BSH-0923-048-001

Pin Bushing XSm/Sm

BSH-0923-048-002

Pin Bushing M/L

DRG-0922-067-01

Glenoid Drill Guide, XSm/Sm

DRG-0922-067-02

Glenoid Drill Guide, Med/Lg

DRL-0920-047-001

Cannulated Center Starter Drill

DRL-0922-080-01

TSS Glenoid Solid Peg Drill

DRL-0923-047-001

Cannulated Peg Drill

GDW-0920-061-501

2.0mm x 150mm Guide Pin

HDL-0920-075-001

Anti-rotation Peg Holder

HDR-0920-063-001

Glenoid Holder

PEG-0922-074-02

TSS Anti-rotation Peg

RMR-0920-057-000

Glenoid Reamer, Extra Small

RMR-0920-057-001

Glenoid Reamer, Small

Glenoid Tray - Container CSA-000-14

Generic Case Lid - Full DIN

CSA-0923-07

TSS Glenoid Inst Tray - Base Assembly

CSA-0923-08

TSS Glenoid Inst Tray - Tray Assembly

CSA-0923-09

TSS Glenoid Inst Tray - Glenoid Caddy

CSA-0923-010

TSS Glenoid Inst Tray - Glenoid Caddy Lid

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

Contraindications: The following conditions are contraindications for reverse total shoulder arthroplasty: • Active local or systemic infection. • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components. • Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid. The following condition is a contraindication for total shoulder arthroplasty: • Absent, irreparable or nonfunctional rotator cuff or other essential muscles. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Titan 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 III 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

Shoulder

Titanâ&#x201E;¢ reverse shoulder system RSS Implant Reference

Description

Humeral Stem STEM-0920-025-06

Press Fit Stem, 6mm

STEM-0920-025-07

Press Fit Stem, 7mm

STEM-0920-025-08

Press Fit Stem, 8mm

STEM-0920-025-09

Press Fit Stem, 9mm

STEM-0920-025-10

Press Fit Stem, 10mm

STEM-0920-025-11

Press Fit Stem, 11mm

STEM-0920-025-12

Press Fit Stem, 12mm

STEM-0920-025-13

Press Fit Stem, 13mm

STEM-0920-025-14

Press Fit Stem, 14mm

STEM-0920-025-15

Press Fit Stem, 15mm

STEM-0920-025-16

Press Fit Stem, 16mm

STEM-0950-025-06

Cemented Stem, 6mm

STEM-0950-025-08

Cemented Stem, 8mm

STEM-0950-025-10

Cemented Stem, 10mm

STEM-0950-025-12

Cemented Stem, 12mm

STEM-0950-025-14

Cemented Stem, 14mm

Humeral Body + Body Screw BBS-0960-21SML

Reverse Body Small and Body Screw

BBS-0960-21STD

Reverse Body Standard and Body Screw

BBS-0960-21LRG

Reverse Body Large and Body Screw

Liner - Standard LNR-0960-00S

Liner, Standard, Size 0 Standard

LNR-0960-03S

Liner, Standard, Size +3 Standard

LNR-0960-06S

Liner, Standard, Size +6 Standard

4.5 mm Screw & Locking Cap

LNR-0960-09S

Liner, Standard, Size +9 Standard

SSC-0960-045-15

4.5 mm Screw and Locking Cap, Lenght 15mm

SSC-0960-045-20

4.5 mm Screw and Locking Cap, Lenght 20mm

Liner - Retentive LNR-0960-00R

Liner, Retentive, Size 0 Retentive

SSC-0960-045-25

4.5mm Screw and Locking Cap, Lenght 25mm

LNR-0960-03R

Liner, Retentive, Size + 3 Retentive

SSC-0960-045-30

4.5 mm Screw and Locking Cap, Lenght 30mm

LNR-0960-06R

Liner, Retentive, Size +6 Retentive

SSC-0960-045-35

4.5 mm Screw and Locking Cap, Lenght 35mm

LNR-0960-09R

Liner, Retentive, Size +9 Retentive

SSC-0960-045-40

4.5 mm Screw and Locking Cap, Lenght 40mm

SSC-0960-045-45

4.5 mm Screw and Locking Cap, Lenght 45mm

GBP-0960-030-15

Glenoid Baseplate, Size 15mm

SSC-0960-045-50

4.5 mm Screw and Locking Cap, Lenght 50mm

GBP-0960-030-25

Glenoid Baseplate, Size 25mm

SSC-0960-045-55

4.5 mm Screw and Locking Cap, Lenght 55mm

Glenoid Baseplate

Glenosphere - Concentric

5.5 mm Screw

GLS-0960-02C

Glenosphere, Concentric, Size 2mm

SCW-0960-055-20

5.5 mm Screw, Lenght 20mm

GLS-0960-05C

Glenosphere, Concentric, Size 5mm

SCW-0960-055-25

5.5 mm Screw, Lenght 25mm

SCW-0960-055-30

5.5 mm Screw, Lenght 30mm

GLS-0960-02E

Glenosphere, Eccentric, Size 2mm

SCW-0960-055-35

5.5 mm Screw, Lenght 35mm

GLS-0960-05E

Glenosphere, Eccentric, Size 5mm

SCW-0960-055-40

5.5 mm Screw, Lenght 40mm

GLS-0960-02EL

Glenosphere, Eccentric with Lip, Size 2mm

SCW-0960-055-45

5.5 mm Screw, Lenght 45mm

Glenosphere - Eccentric

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

Shoulder

Instrument Reference

Humeral Tray 1 - Insert Description

Humeral Tray 1 - Base

AWL-0920-042-001

Starter Awl

GAU-0920-058-001

Head Cutting Depth Gauge

ADT-0920-065-001

Taper Adapter

HSG-0920-041-001

Head Sizing Gauge 38-46

HDL-0920-043-001

Stem Trial Handle

HSG-0920-041-002

Head Sizing Gauge 48-52

INS-0920-046-001

Humeral Trial Inserter/ Extractor

NR135004-J-004

T-Handle w/ Lg AO

INS-0950-046-001

Humeral Fracture Trial Inserter/Extractor

PIN-0920-051-001

Fixation pin

RMR-0920-050-001

Calcar Planer, Small

PUL-0920-087-01

Pin Puller

RMR-0920-050-002

Calcar Planer, Large

ROD-0920-040-002

Head Cutting Template Handle

SCR-0920-066-001

Taper Adapter Shaft

SET189-A001

Head Cutting Guide

TDT-0920-044-001

Taper Disassembly Tool

SET189-D007

Version Rod

TRL-0920-020-08STD

Body Trial, 8 Standard

TMP-0920-040-001L

Head Cutting Template, Left

TRL-0920-020-10LRG

Body Trial, 10 Large

TMP-0920-040-001R

Head Cutting Template, Right

TRL-0920-020-10SML

Body Trial, 10 Small

Humeral Tray 1 - Container

TRL-0920-020-10STD

Body Trial, 10 Standard

CSA-000-14

Generic Case Lid - Full DIN

TRL-0920-020-12STD

Body Trial, 12 Standard

CSA-0920-15

TSS Humeral Inst Set 1 Case Base

TRL-0920-020-14LRG

Body Trial, 14 Large

CSA-0920-16

TSS Humeral Inst Set 1 Insert Tray

TRL-0920-020-14SML

Body Trial, 14 Small

CSA-0920-17

TSS Humeral Inst Set 1 Prox Trial Caddy Base

TRL-0920-020-14STD

Body Trial, 14 Standard

CSA-0920-18

TSS Humeral Inst Set 1 Prox Trial Caddy Lid

TRL-0950-020-08LRG

Fracture Body Trial, 8 Large

CSA-0920-19

TSS Humeral Inst Set 1 Tray Taper Adap Caddy Base

TRL-0950-020-08SML

Fracture Body Trial, 8 Small

CSA-0920-20

TSS Humeral Inst Set 1 Tray Taper Adap Caddy Lid

TRL-0950-020-08STD

Fracture Body Trial, 8 Standard

TRL-0920-025-06

Humeral Stem Trial, 6mm

TRL-0920-025-07

Humeral Stem Trial, 7mm

TRL-0920-025-08

Humeral Stem Trial, 8mm

TRL-0920-025-09

Humeral Stem Trial, 9mm

TRL-0920-025-10

Humeral Stem Trial, 10mm

TRL-0920-025-11

Humeral Stem Trial, 11mm

TRL-0920-025-12

Humeral Stem Trial, 12mm

TRL-0920-025-13

Humeral Stem Trial, 13mm

TRL-0920-025-14

Humeral Stem Trial, 14mm

TRL-0920-025-15

Humeral Stem Trial, 15mm

TRL-0920-025-16

Humeral Stem Trial, 16mm

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

Shoulder

HSP-0920-070-008

Head Sizing Plate, 52mm

TRL-0920-010-3814E

Head Trial, Ecc, Size 38x14mm

TRL-0920-010-4015E

Head Trial, Ecc, Size 40x15mm

TRL-0920-010-4216C

Head Trial, Cen, Size 42x16mm

TRL-0920-010-4216E

Head Trial, Ecc, Size 42x16mm

TRL-0920-010-4416C

Head Trial, Cen, Size 44x16mm

TRL-0920-010-4416E

Head Trial, Ecc, Size 44x16mm

TRL-0920-010-4419C

Head Trial, Cen, Size 44x19mm

TRL-0920-010-4419E

Head Trial, Ecc, Size 44x19mm

TRL-0920-010-4614C

Head Trial, Cen, Size 46x14mm

TRL-0920-010-4614E

Head Trial, Ecc, Size 46x14mm

TRL-0920-010-4617C

Head Trial, Cen, Size 46x17mm

TRL-0920-010-4617E

Head Trial, Ecc, Size 46x17mm

Stem Impactor

TRL-0920-010-4620C

Head Trial, Cen, Size 46x20mm

IMP-0920-079-501

TSS Head Impactor

TRL-0920-010-4620E

Head Trial, Ecc, Size 46x20mm

INS-0920-045-001

Humeral Implant Inserter/ Extractor

TRL-0920-010-4815C

Head Trial, Cen, Size 48x15mm

INS-0920-071-LRG

Head Impaction Stand Insert, Large

TRL-0920-010-4815E

Head Trial, Ecc, Size 48x15mm

INS-0920-071-SML

Head Impaction Stand Insert, Small

TRL-0920-010-4818C

Head Trial, Cen, Size 48x18mm

INS-0920-071-STD

Head Impaction Stand Insert, Std

TRL-0920-010-4818E

Head Trial, Ecc, Size 48x18mm

INS-0950-045-001

Humeral Fracture Implant Inserter/Extractor

TRL-0920-010-4821C

Head Trial, Cen, Size 48x21mm

MAL-0920-085-01

Slotted Mallet

TRL-0920-010-4821E

Head Trial, Ecc, Size 48x21mm

SCR-0920-060-001

1/8 Hexdriver

TRL-0920-010-5019C

Head Trial, Cen, Size 50x19mm

SEP-0920-068-001

Body Separator

TRL-0920-010-5019E

Head Trial, Ecc, Size 50x19mm

SET188-A001

Head Extractor

TRL-0920-010-5022C

Head Trial, Cen, Size 50x22mm

SIS-0920-054-001

Stem Impaction Stand

TRL-0920-010-5022E

Head Trial, Ecc, Size 50x22mm

STD-0920-071-001

Head Impaction Stand, Base Assembly

TRL-0920-010-5220C

Head Trial, Cen, Size 52x20mm

TRQ-0920-086-01

Torque Limiter

TRL-0920-010-5220E

Head Trial, Ecc, Size 52x20mm

Instrument Reference

Description

Humeral Tray 2 - Base IMP-0920-055-001

Humeral Tray 2 - Container CSA-000-14

Generic Case Lid - Full DIN

CSA-0920-21

TSS Humeral Inst Set Case Base

CSA-0920-22

TSS Humeral Inst Set Insert Tray

Humeral Tray 2 - Insert

G107992_B

Driver Handle w/ Sm AO

HSP-0920-070-001E

Head Sizing Plate, 38mm

HSP-0920-070-002E

Head Sizing Plate, 40mm

HSP-0920-070-003

Head Sizing Plate, 42mm

HSP-0920-070-004

Head Sizing Plate, 44mm

HSP-0920-070-005

Head Sizing Plate, 46mm

HSP-0920-070-006

Head Sizing Plate, 48mm

HSP-0920-070-007

Head Sizing Plate, 50mm

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

Shoulder

Instrument Reference

Glenoid Tray - Insert Description

Glenoid Tray - Base

BSH-0920-048-001

Pin Bushing

BSH-0920-048-002

Center Starter Drill Bushing

HDL-0922-082-01

Glenoid Drill Shaft

DRG-0920-049-001

Center Glenoid Drill Guide, X-Sm/Sm

IMP-0920-064-001

Glenoid Impactor

DRG-0920-049-002

Center Glenoid Drill Guide, Med/Lg

PUN-0920-062-001

Glenoid Keel Punch, XSm/Sm

DRG-0922-067-01

Glenoid Drill Guide, X-Sm/Sm

PUN-0920-062-002

Glenoid Keel Punch, Med/Lg

DRG-0922-067-02

Glenoid Drill Guide, Med/Lg

PUN-0920-072-001

Glenoid Peg Punch, XSm/Sm

DRL-0920-047-001

Cannulated Center Starter Drill

PUN-0920-072-002

Glenoid Peg Punch, Med/Lg

DRL-0920-047-002

Cannulated Peg Drill

DRL-0920-056-001

Solid Center Starter Drill

DRL-0922-080-01

TSS Glenoid Solid Peg Drill

GDW-0920-061-501

2.0mm x 150mm Guide Pin

HDL-0920-075-001

Anti-rotation Peg Holder

HDR-0920-063-001

Glenoid Holder

PEG-0922-074-02

TSS Anti-rotation Peg

RMR-0920-057-000

Glenoid Reamer, Extra Small

RMR-0920-057-001

Glenoid Reamer, Small

RMR-0920-057-002

Glenoid Reamer, Medium

RMR-0920-057-003

Glenoid Reamer, Large

SZR-0920-052-000

Glenoid Sizer, Extra Small

SZR-0920-052-001

Glenoid Sizer, Small

SZR-0920-052-002

Glenoid Sizer, Medium

SZR-0920-052-003

Glenoid Sizer, Large

TRL-0920-030-00K

Glenoid, Keel Trial, Extra Small

TRL-0920-030-00P

Glenoid, Peg Trial, Extra Small

TRL-0920-030-01K

Glenoid, Keel Trial, Small

TRL-0920-030-01P

Glenoid, Peg Trial, Small

TRL-0920-030-02K

Glenoid, Keel Trial, Medium

TRL-0920-030-02P

Glenoid, Peg Trial, Medium

TRL-0920-030-03K

Glenoid, Keel Trial, Large

TRL-0920-030-03P

Glenoid, Peg Trial, Large

Glenoid Tray - Container CSA-000-14

Generic Case Lid - Full DIN

CSA-0920-23

TSS Glenoid Inst Set Case Base

CSA-0920-24

TSS Glenoid Inst Set Insert Tray

CSA-0920-25

TSS Glenoid Inst Set Caddy Base

CSA-0920-26

TSS Glenoid Inst Set Caddy Lid

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

Shoulder

Instrument Reference

Reverse Tray - Insert Description

Reverse Tray - Base

DEP-0960-069-01

RSS Stem Depth Stop

BDG-0960-074-01

Baseplate Boss Drill Guide

DEP-0960-069-01

RSS Stem Depth Stop

DDG-0960-077-01

Double Drill Guide for 2.5mm/2.8mm Drills

DGB-0960-08LRG

Definitive Stem RSS Reamer Guide Body, Large

DRL-0960-054-15

Cannulated Drill for 15mm Central Peg

DGB-0960-08SML

Definitive Stem RSS Reamer Guide Body, Small

DRL-0960-054-25

Cannulated Drill for 25mm Central Peg

DGB-0960-08STD

Definitive Stem RSS Reamer Guide Body, Standard

DRL-0960-061-01

2.5mm Drill Bit for 4.5mm Screw

DTL-0960-08LRG

Definitive Stem RSS Body Trial, Large

DRL-0960-068-01

2.8mm Drill bit for 5.5mm Screw

DTL-0960-08SML

Definitive Stem RSS Body Trial, Small

DRL-0960-075-01

Baseplate Boss Drill

DTL-0960-08STD

Definitive Stem RSS Body Trial, Standard

GWG-0960-050-CL

Glenoid Wire Guide Concentric With Lip

TRL-0960-08LRG

RSS Humeral Body Trial, Large

GWG-0960-050-EL

Glenoid Wire Guide Eccentric With Lip

TRL-0960-08SML

RSS Humeral Body Trial, Small

GWG-0960-053-01

Glenoid Wire Guide

TRL-0960-08STD

RSS Humeral Body Trial, Standard

HDL-0960-065-01

Glenosphere Inserter

RGB-0960-08LRG

Humeral Reamer Guide Body, Large

HDL-0960-067-01

Glenosphere Removal Handle

RGB-0960-08SML

Humeral Reamer Guide Body, Small

IMP-0960-064-01

Glenoid Baseplate Impactor

RGB-0960-08STD

Humeral Reamer Guide Body, Standard

IMP-0960-066-01

Glenosphere Impactor

IMC-0960-043-01

IM Head Cutting Guide, 142°

PEG-0960-073-01

RSS Anti-Rotation Baseplate Peg

IMP-0960-071-01

Liner Impactor

RDG-0960-078

RSS Depth Gauge

IMS-0960-070-01

RSS Stem Impaction Stand

RMR-0960-076-01

Peripheral Reamer, Concentric

INS-0960-048-01

Humeral Body Inserter/Extractor

RMR-0960-076-02

Peripheral Reamer, Eccentric

INS-0960-049-01

Reamer Guide Body Inserter/Extractor

SCR-0960-062-01

2.5mm Hex for 4.5mm screw

INS-0960-049-02

Reamer Guide Body Inserter/Extractor Knob

SCR-0960-063-01

Slotted Torx-15 for 4.5mm Screw Locking Cap

INS-0960-094-01

Humeral Body Inserter/Extractor Knob

SCR-0960-072-01

Torx-25 Screwdriver Shaft with Quick Connect

RMR-0960-047-01

Humeral Reamer

TRL-0960-02C

Glenosphere Trial, 2mm Concentric

TMP-0960-01L

Head Cutting Template, 142° Left

TRL-0960-02E

Glenosphere Trial, 2mm Eccentric

TMP-0960-01R

Head Cutting Template, 142° Right

TRL-0960-02EL

Glenosphere Trial, 2mm Eccentric Lipped

TRL-0960-00R

Retentive Poly Trial Liner, +0

TRL-0960-05C

Glenosphere Trial, 5mm Concentric

TRL-0960-00S

Standard Poly Trial Liner, + 0

TRL-0960-05E

Glenosphere Trial, 5mm Eccentric

TRL-0960-03R

Retentive Poly Trial Liner, +3

Reverse Tray - Container

TRL-0960-03S

Standard Poly Trial Liner, +3

CSA-0960-01

RSS Instrument Set Base

TRL-0960-06R

Retentive Poly Trial Liner, +6

CSA-0960-02

RSS Instrument Set Insert

TRL-0960-06S

Standard Poly Trial Liner, +6

CSA-000-14

Generic Case Lid

TRL-0960-09R

Retentive Poly Trial Liner, +9

TRL-0960-09S

Standard Poly Trial Liner, +9

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

Shoulder

Titan™ reverse shoulder system Indications: Reverse Total Shoulder System is indicated for: Use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use. Contraindications: The following conditions are contraindications for reverse total shoulder arthroplasty: • Patients without a functional deltoid musclePrevious open fracture or infection of the joint; • Active local or systemic infection; • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components; • Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid; • Pregnancy; • Muscular, neurologic, or vascular deficiencies that compromise the affected extremity; • Known metal allergies.

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 50 Fax: +33(0)4 37 47 59 30

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

Shoulder

Shoulder retractors

Implant Reference

Description

RET-920-11S

Darrach Retractor-Small

RET-920-11L

Darrach Retractor-Large

RET-920-20

Deltoid Retractor-Large

RET-920-31

Hohman Retractor

RET-920-41S

Glenoid Retractor-Small

RET-920-41L

Glenoid Retractor-Large

RET-920-50S

Fukuda Retractor-Small

RET-920-50L

Fukuda Retractor-Large

RET-920-60

Kolbel Retractor Frame

RET-920-61S

Kolbel Retractor-Small

RET-920-61L

Kolbel Retractor-Large

RET-920-61XL

Kolbel Retractor-XLarge

CONTAINER CSA-000-14

Generic Case Lid – Full DIN

CSA-925-02

TSS Retractor Tray Base

Shoulder retractors DESCRIPTION AND INTENDED USE: Integra LifeSciences Corporation reusable surgical device sets consist of various configurations of orthopedic devices in cases or trays. The sets are constructed from durable metal and/or plastic materials. The reusable surgical devices are intended for use in orthopedic surgical procedures according to the Instructions for Use and Surgical techniques that accompany Integra® implants. Reusable devices are to be cleaned, inspected, and sterilized between uses INSPECTION BEFORE USE: Reusable Devices can be used indefinitely if not damaged or worn. Device systems should be cleaned and then inspected between uses. DO NOT use broken or damaged devices. Contact Integra for repair or replacement of damaged items. If damage or malfunction is detected, the device should not be used. Disposable Devices should be disposed of according to hospital procedure and any applicable laws. The following conditions are contraindications for reverse total shoulder arthroplasty: 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 and 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

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

Shoulder

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

Shoulder

Titan™ long stem - long stem & anatomic bodies for revision cases

Implant Reference

Description

STEM-0950-025-08125

Cemented Long Stem, 8mmx125mm

STEM-0950-025-08165

Cemented Long Stem, 8mmx165mm

STEM-0950-025-10125

Cemented Long Stem, 10mmx125mm

STEM-0950-025-10165

Cemented Long Stem, 10mmx165mm

STEM-0950-025-12125

Cemented Long Stem, 12mmx165mm

STEM-0950-025-12165 Cemented Long Stem, 12mmx165mm

Instrument

Reference

Description

RMR-0950-025-08125

Reamer Cemented Long Stem, 8mm x 125mm

CONTAINER

RMR-0950-025-10125

Reamer Cemented Long Stem, 10mm x 125mm

CSA-0950-01

Humeral Long Stem Tray Base

RMR-0950-025-12125

Reamer Cemented Long Stem, 12mm x 125mm

CSA-0950-02

Humeral Long Stem Insert Tray

RMR-0950-025-14125

Reamer Cemented Long Stem, 14mm x 125mm

CSA-000-16

TSS modified green lid

RMR-0950-025-08165

Reamer Cemented Long Stem, 8mm x 165mm

CSA-0923-03

TSS Humeral Instrument Set 1 Proximal Trial Caddy Base

RMR-0950-025-10165

Reamer Cemented Long Stem, 10mm x 165mm

CSA-0923-04

TSS Humeral Instrument Tray 1 - Body Cady Lid

RMR-0950-025-12165

Reamer Cemented Long Stem, 12mm x 165mm

RMR-0950-025-14165

Reamer Cemented Long Stem, 14mm x 165mm

ADA-0950-040-501

Trial Adaptor

ADA-0950-040-502

Stem Adaptor

SLP-1002-519

Slap Hammer

TRL-0950-025-08125

Trial Cemented Long Stem, 8mmx125mm

TRL-0950-025-10125

Trial Cemented Long Stem, 10mmx125mm

TRL-0950-025-12125

Trial Cemented Long Stem, 12mmx125mm

TRL-0950-025-08165

Trial Cemented Long Stem, 8mmx165mm

TRL-0950-025-10165

Trial Cemented Long Stem, 10mmx165mm

TRL-0950-025-12165

Trial Cemented Long Stem, 12mmx165mm

TRL-0920-120-08STD

Definitive Stem Primary Body Trial – 08 Std

TRL-0920-120-10SML

Definitive Stem Primary Body Trial – 10 Sml

TRL-0920-120-10STD

Definitive Stem Primary Body Trial – 10 Std

TRL-0920-120-10LRG

Definitive Stem Primary Body Trial – 10 Lrg

TRL-0920-120-12STD

Definitive Stem Primary Body Trial – 12 Std

TRL-0920-120-14SML

Definitive Stem Primary Body Trial – 14 Sml

TRL-0920-120-14STD

Definitive Stem Primary Body Trial – 14 Std

TRL-0920-120-14LRG

Definitive Stem Primary Body Trial – 14 Lrg

TRL-0923-121-08SML

Definitive Stem Fracture Body Trial – 08 Sml

TRL-0923-121-08STD

Definitive Stem Fracture Body Trial –08 Std

TRL-0923-121-08LRG

Definitive Stem Fracture Body Trial –08 Lrg

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

Shoulder

Titan™ long stem - long stem & anatomic body for revision cases Indications: Total Shoulder Arthroplasty or Hemiarthroplasty is indicated for: • Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; • Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; • Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component); Shoulder Hemiarthroplasty is also indicated for: • Ununited humeral head fractures. • Avascular necrosis of the humeral head. • Rotator cuff arthropathy. • Deformity and/or limited motion. • The humeral component is intended for cemented or un-cemented use. • The glenoid component is intended for cemented use only.

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

Reverse Total Shoulder System is indicated for: Use in a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated forcemented or uncemented use and the humeral body component is intended for cementless use. Contraindications: The following conditions are contraindications for total shoulder arthroplasty and hemiarthroplasty: • Active local or systemic infection. • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components. • Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid. • The following condition is a contraindication for total shoulder arthroplasty: • Absent, irreparable or nonfunctional rotator cuff or other essential muscles. The following conditions are contraindications for reverse total shoulder arthroplasty: • Patients without a functional deltoid muscle • Active local or systemic infection. • Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components; • Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid; • Pregnancy; • Muscular, neurologic, or vascular deficiencies that compromise the affected extremity; • Known metal allergies; Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Titan 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 III 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

Shoulder

Titan™ humeral resurfacing arthroplasty HRA Implant Reference

Description

HRA-900-40/16-WW

HRA Component Sz. 40/16

HRA-900-44/15-WW

HRA Component Sz. 44/15

HRA-900-44/18-WW

HRA Component Sz. 44/18

HRA-900-48/17-WW

HRA Component Sz. 48/17

HRA-900-48/20-WW

HRA Component Sz. 48/20

HRA-900-52/18-WW

HRA Component Sz. 52/18

HRA-900-52/21-WW

HRA Component Sz. 52/21

HRA-900-56/21-WW

HRA Component Sz. 56/21

Instrument

Reference

Description

SZR-900-40-16

HRA Sizer / Centralizer, Size 40/16

BRH-900-02

HRA Broach, Size 2

SZR-900-44-15

HRA Sizer / Centralizer, Size 44/15

BRH-900-03

HRA Broach, Size 3

SZR-900-44-18

HRA Sizer / Centralizer, Size 44/18

BRH-900-00

HRA Broach, Starter Broach

SZR-900-48-17

HRA Sizer / Centralizer, Size 48/17

IMP-900-01

HRA Impactor

SZR-900-48-20

HRA Sizer / Centralizer, Size 48/20

RET-900-01

HRA Retractor

SZR-900-52-18

HRA Sizer / Centralizer, Size 52/18

605 283 230

3.0mm x 230mm Partial Threaded Kirschner

SZR-900-52-21

HRA Sizer / Centralizer, Size 52/21

605 280 230

3.0mm x 230mm Kirschner Non-Threaded

SZR-900-56-21

HRA Sizer / Centralizer, Size 56/21

CONTAINER

SHP-900-40-16

HRA Shaper, Size 40/16

CSA-900-01

Lid

SHP-900-44-15

HRA Shaper, Size 44/15

CSA-900-02

Case

SHP-900-44-18

HRA Shaper, Size 44/18

CSA-900-03

HRA Top Tray

SHP-900-48-17

HRA Shaper, Size 48/17

CSA-900-04

HRA Bottom Tray

SHP-900-48-20

HRA Shaper, Size 48/20

SHP-900-52-18

HRA Shaper, Size 52/18

SHP-900-52-21

HRA Shaper, Size 52/21

SHP-900-56-21

HRA Shaper, Size 56/21

CTD-900-01

HRA Center Drill, Size 1

CTD-900-02

HRA Center Drill, Size 2

CTD-900-03

HRA Center Drill, Size 3

TRL-900-40-16

HRA Trial, Size 40/16

TRL-900-44-15

HRA Trial, Size 44/15

TRL-900-44-18

HRA Trial, Size 44/18

TRL-900-48-17

HRA Trial, Size 48/17

TRL-900-48-20

HRA Trial, Size 48/20

TRL-900-52-18

HRA Trial, Size 52/18

TRL-900-52-21

HRA Trial, Size 52/21

TRL-900-56-21

HRA Trial, Size 56/21

ADP-900-01

HRA Adapter Plug, Size 1

ADP-900-02

HRA Adapter Plug, Size 2

ADP-900-03

HRA Adapter Plug, Size 3

BRH-900-01

HRA Broach, Size 1

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

Shoulder

Titan™ humeral resurfacing arthroplasty Indications: The Ascencion® HRA® System is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis, mild or moderate humeral head deformity and/or limited motion, post-traumatic arthritis, and patients with an intact or reparable rotator cuff. Contraindications: Absolute contraindications include:infection, sepsis, and osteomyelitis. Relative contraindications include: osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, revision procedures where other devices or treatments have failed with associated loss of bone stock. Integra is a registered trademark of Integra LifeSciences Corporation in the United States and/or other countries. Titan 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.

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

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

Notes

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

Notes

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

Integra® Shoulder & Elbow Solutions Product Catalog 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. Katalyst and Titan are trademarks of Integra LifeSciences Corporation in the United State and / or other countries. Ascension, 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: 01/2018. 0829104-2-EN DOCUMENT FOR USE IN EUROPE, MIDDLE-EAST and AFRICA ONLY.