Acetabular

Main information

  • Trade name:
  • Acetabular shell
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Acetabular shell
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218018
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218018

Stryker Australia Pty Ltd - TRIDENT TRITANIUM HEMISPHERICAL SHELL - Acetabular shell

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

3/12/2013

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. Acetabular shell

Product Type

Single Device Product

Effective date

3/12/2013

GMDN

43167 Acetabular shell

Functional description

This Acetabular Shell is the outer portion of a two-piece acetabulum prosthesis. It is sterile, made of

Titanium, is pressfit to the pelvis with out the use of cement. Option to use screws for additional fixation.

Dome hole plug included in solid shell option. An Acetabular Insert is implanted within to provide an

articulating surface for an artificial Femoral Head, part of a Total Hip Arthroplasty (THA). These come in a

range of sizes for compatibility and sizing options

Intended purpose

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

Indication:

Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis,

post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head

replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or

alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of

poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the

acetabulum.

Variant information

Diameter (mm) 54mm - 72mm

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 12:12:51 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