Maxim Knee System Biomet finned primary modular stem 40X46MM - Uncoated knee tibia prosthesis, metallic

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Zimmer Biomet Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
293517

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Public Summary

Summary for ARTG Entry:

293517

Zimmer Biomet Pty Ltd - Maxim Knee System Biomet finned primary modular stem 40X46MM - Uncoated

knee tibia prosthesis, metallic

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

4/09/2017

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Biomet Orthopedics

56 East Bell Drive PO Box 587

Warsaw, IN, 46581

United States Of America

Products

1. Maxim Knee System Biomet finned primary modular stem 40X46MM - Uncoated knee tibia prosthesis,

metallic

Product Type

Single Device Product

Effective date

4/09/2017

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

Titanium alloy 46 X 40 MM modular finned stem. For use with Biomet modular tibial trays; packaged with

screw. The combination of a Morse-type taper and screw fixation helps maintain a solid connection

between the stem and baseplate. When more fixation is desired, the stemmed or offset tray will accept a

40, 80, 120, 160, or 200 mm stem extension.

Intended purpose

Titanium alloy finned primary tibial stem. Indications for use include: Painful and disabled knee joint

resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are

involved; Correction of varus, valgus, or post-traumatic deformity; Correction or revision of unsuccessful

osteotomy, arthrodesis, or failure of previous joint replacement procedure

Variant information

Nil variant (as 1 device) Nil

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 03.11.2017 at 04:22:15 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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