Uniglide

Main information

  • Trade name:
  • Uniglide Femur Cementless - Coated unicondylar knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uniglide Femur Cementless - Coated unicondylar knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216335
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216335

Corin Australia Pty Ltd - Uniglide Femur Cementless - Coated unicondylar knee femur prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Corin Australia Pty Ltd

Postal Address

PO Box 205,PYMBLE, NSW, 2073

Australia

ARTG Start Date

22/10/2013

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

Corin Limited

The Corinium Centre Cirencester

, Gloucestershire, GL7 1YJ

Products

1. Uniglide Femur Cementless - Coated unicondylar knee femur prosthesis

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

34209 Coated unicondylar knee femur prosthesis

Functional description

The femoral component is from cast cobalt chrome. The bearing surface is coated with a titanium nitride

coating (TiN). The system is available in as a mobile bearing option and a fixed bearing option. The mobile

bearing system is designed to provide highly congruent articulation and the fixed bearing system is

designed to provide a flat articulation. Cementless fixation is promoted by use of a calcium phosphate

coating on a plasma sprayed titanium coating.

Intended purpose

The Uniglide femur cementless is a component of the Uniglide Unicondylar Knee System indicated for

patients with

unicompartmental disease and intact ligaments, particularly the ACL

Variant information

Size 2-4

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 05:17:38 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