ADVANCE

Main information

  • Trade name:
  • ADVANCE® Posterior Stabilized Nonporous CoCr Femoral Knee Components - Posterior-stabilized total knee prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • ADVANCE® Posterior Stabilized Nonporous CoCr Femoral Knee Components - Posterior-stabilized total knee prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216716
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216716

MicroPort Orthopedics Pty Ltd- ADVANCE® Posterior Stabilized Nonporous CoCr Femoral Knee

Components - Posterior-stabilized total knee 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

30/10/2013

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

MicroPort Orthopedics Inc

5677 Airline Road

Arlington, TN, 38002

United States Of America

Products

1. ADVANCE® Posterior Stabilized Nonporous CoCr Femoral Knee Components - Posterior-stabilized total

knee prosthesis

Product Type

Single Device Product

Effective date

30/10/2013

GMDN

33665 Posterior-stabilized total knee prosthesis

Functional description

This device is a posterior stabilized nonporous CoCr knee femoral component used to replace the distal

femur of a knee joint in skeletally mature patients. It is designed to articulate with UHMWPE tibial inserts

and, if required, UHMWPE patellar prosthetic components of the knee joint.

Intended purpose

Wright Total Knee Systems are 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

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 04:27:40 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

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Our aim: ensure that devices not only meet the gold standard for getting to market but continue to meet this standard as we get more data and learn more about their benefit-risk profile in real-world settings. These new approaches will also help advance b

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