CONSTRAINED

Main information

  • Trade name:
  • CONSTRAINED ACETABULAR INSERT - Constrained polyethylene acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CONSTRAINED ACETABULAR INSERT - Constrained polyethylene acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217730
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217730

Stryker Australia Pty Ltd - CONSTRAINED ACETABULAR INSERT - Constrained polyethylene acetabular

liner

ARTG entry for

Medical Device Included Class III

Sponsor

Stryker Australia Pty Ltd

Postal Address

PO Box 970,ARTARMON, NSW, 1570

Australia

ARTG Start Date

25/11/2013

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

Howmedica Osteonics Corporation

325 Corporate Drive

Mahwah, New Jersey, 07430

United States Of America

Products

1. CONSTRAINED ACETABULAR INSERT - Constrained polyethylene acetabular liner

Product Type

Single Device Product

Effective date

25/11/2013

GMDN

44362 Constrained polyethylene acetabular liner

Functional description

Two pre-assembled components: Acetabular Insert and Femoral Head (UHR). The UHR has a factory

assembled UHMWPE retention ring. The outer acetabular insert has a Ti alloy retaining ring which retains

the UHR Head in the plastic portion of the insert and a CoCr alloy circumferential locking wire for secure

assembly of the insert to the metal shell. The Constrained Acetabular Insert is designed to be assembled

with a 50 mm or larger outer diameter Standard Profile Metal Acetabular Shell.

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. The

Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and

revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft

tissue laxity, neuromuscular disease, or intraoperative instability.

Variant information

Diameter (mm) Femoral Head 22mm - 28mm

Diameter (mm) Outer 50mm - 74mm

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 01:13:51 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