Uniglide

Main information

  • Trade name:
  • Uniglide Tibial Insert Mobile - Unicondylar knee insert
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uniglide Tibial Insert Mobile - Unicondylar knee insert
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216336
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216336

Corin Australia Pty Ltd - Uniglide Tibial Insert Mobile - Unicondylar knee insert

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 Tibial Insert Mobile - Unicondylar knee insert

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

48070 Unicondylar knee insert

Functional description

The mobile bearing insert is manufactured from GUR 1050 UHMWPE extruded bar to ISO5834-2. Mobile

bearing inserts are provided in three sizes, to match the sizes of the femoral component. Each size is

provided in a range of nine thicknesses from 4 mm to 12 mm in 1 mm increments.

The distal and sagittal surfaces of the component are flat and designed to articulate with the polished

surfaces of the tibial base plate. The proximal bearing surface of the component has a concave spherical

form.

Intended purpose

The Uniglide Tibial Insert Mobile is a component of the Uniglide Mobile Bearing Unicondylar Knee System

indicated for use in

patients with osteoarthritis limited to the medial compartment of the knee

Variant information

Size 2-4

Thickness 4-12

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 05:17:22 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