Uncoated

Main information

  • Trade name:
  • Uncoated knee femur prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Uncoated knee femur prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220420
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220420

MicroPort Orthopedics Pty Ltd- ADVANCE® Revision Nonporous CoCr Femoral Knee Components -

Uncoated knee femur prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

MicroPort Orthopedics Pty Ltd

Postal Address

PO Box 6052,Frenchs Forest, NSW, 1640

Australia

ARTG Start Date

24/02/2014

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

MicroPort Orthopedics Inc

5677 Airline Road

Arlington, TN, 38002

United States Of America

Products

1. Uncoated knee femur prosthesis

Product Type

Single Device Product

Effective date

24/02/2014

GMDN

32831 Uncoated knee femur prosthesis

Functional description

A nonporous CoCr device with a spine and cam mechanism used to replace the distal femur of a knee

joint in skeletally mature patients. It accepts traditional posterior-stabilized or constrained UHMWPE tibial

inserts and, if required, UHMWPE patellar components of the knee joint. This device is indicated for use in

both primary and revision knee replacement surgeries; however, it is mainly used in revision scenarios

when additional constraint and fixation (via stem extensions) are required.

Intended purpose

A total knee system component used to replace the distal femur. Indicated for use in knee arthroplasty in

skeletally mature patients with the following conditions:

1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular

necrosis;

2. Inflammatory degenerative joint disease including rheumatoid arthritis;

3. Correction of functional deformity;

4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are

unmanageable using other techniques.

Variant information

Shape left & right

Size 1-6

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 04:08:19 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