Uniglide

Main information

  • Trade name:
  • Uniglide Tibia Fixed All Poly - Prosthesis, internal, joint, knee, unicondylar
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uniglide Tibia Fixed All Poly - Prosthesis, internal, joint, knee, unicondylar
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216337
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216337

Corin Australia Pty Ltd - Uniglide Tibia Fixed All Poly - Prosthesis, internal, joint, knee, unicondylar

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 Tibia Fixed All Poly - Prosthesis, internal, joint, knee, unicondylar

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

32833 Prosthesis, internal, joint, knee, unicondylar

Functional description

The fixed tibia is provided in three sizes, denoted size 3, size 5 and size 7. Each size fixed tibia is provided

in four thicknesses, 7mm, 9mm, 11mm and 13mm and can be used in conjunction with any size femoral

component.

The fixed tibia is designed for cemented use only. The proximal bearing surface of the device is flat to

allow unconstrained articulation with the femoral component. The distal surface features a large keel and

cement keying features to provide secure cemented fixation.

Intended purpose

The Uniglide Unicompartmental Knee replacement system is indicated for use in the treatment of

degeneration of the tibio-femoral joint, usually associated with arthritis, which is largely confined to a single

compartment.

Variant information

Size 3-7

Thickness 7-13

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 05:17:06 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