UNIX

Main information

  • Trade name:
  • UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Unicondylar knee insert
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Unicondylar knee insert
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216613
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216613

Stryker Australia Pty Ltd - UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Unicondylar knee insert

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

28/10/2013

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. UNIX UNICONDYLAR KNEE TIBIAL INSERTS - Unicondylar knee insert

Product Type

Single Device Product

Effective date

28/10/2013

GMDN

48070 Unicondylar knee insert

Functional description

A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and

articulates with an artificial Femoral Component on the corresponding condyle. A component of the Unix

unicompartmental Knee System intended to replace the bearing surface of one tibial condyle (medial or

lateral condyle) of the knee joint. made of polyethylene (UHWMPE).

Intended purpose

A modular unicondylar knee that replaces the bearing surfaces of one femoral condyle and the

corresponding tibial condyle, to achieve reconstruction replacement of the deficient knee component.

Indication: Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic

arthritis. Revision of previous unsuccessful unicompartmental knee replacement or other procedure. As an

alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

Variant information

Thickness 8mm - 15mm

Size 1-4

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 04:43:31 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