Zimmer

Main information

  • Trade name:
  • Zimmer® Unicompartmental Knee System, Tibial Component, Precoat - Uncoated knee tibia prosthesis, metallic
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Zimmer® Unicompartmental Knee System, Tibial Component, Precoat - Uncoated knee tibia prosthesis, metallic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220169
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220169

Zimmer Pty Ltd - Zimmer® Unicompartmental Knee System, Tibial Component, Precoat - 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

14/02/2014

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

Zimmer Inc

1800 West Center Street

WARSAW, INDIANA, 46580

United States Of America

Products

1. Zimmer® Unicompartmental Knee System, Tibial Component, Precoat - Uncoated knee tibia prosthesis,

metallic

Product Type

Single Device Product

Effective date

14/02/2014

GMDN

32832 Uncoated knee tibia prosthesis, metallic

Functional description

Designed for the surface reconstruction of individual tibial condyles and made from Zimaloy®

Cobalt-Chromium-Molybdenum Alloy. They are indicated for cemented use only.

Intended purpose

Non porous Tibial baseplate component of the Zimmer® Unicompartmental Knee System prosthesis

indicated for patients with:

- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.

- Previous tibial condyle or plateau fractures with loss of anatomy or function.

- Varus or valgus deformities.

- Revision of previous arthroplasty procedures.

Variant information

Shape Right Medial/Left Lateral

Shape Left Medial/Right Lateral

Size 1-6

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 10.11.2017 at 05:02:56 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