Uniglide

Main information

  • Trade name:
  • Uniglide Tibia Mobile Cementless - Coated unicondylar knee tibia prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uniglide Tibia Mobile Cementless - Coated unicondylar knee tibia prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216339
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216339

Corin Australia Pty Ltd - Uniglide Tibia Mobile Cementless - Coated unicondylar knee tibia 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 Tibia Mobile Cementless - Coated unicondylar knee tibia prosthesis

Product Type

Single Device Product

Effective date

22/10/2013

GMDN

48065 Coated unicondylar knee tibia prosthesis

Functional description

The tibial base plate is offered in seven sizes, denoted size 2 to size 8 and can be used with any meniscal

insert or femur. The main bearing surface is a flat polished surface which is TiN coated and is designed to

articulate against the distal surface of the meniscal insert.

The distal surface of the tibial base plate is designed to be fixed to the tibial bone. The distal surface and

keel are coated with a calcium phosphate coating on a plasma sprayed titanium coating.

Intended purpose

The Uniglide Tibia Mobile Cementless 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. It is intended for

cementless fixation

Variant information

Size 2-8

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 05:16:33 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