TRIDENT

Main information

  • Trade name:
  • TRIDENT ALUMINA CERAMIC ACETABULAR INSERT - Ceramic acetabular liner
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • TRIDENT ALUMINA CERAMIC ACETABULAR INSERT - Ceramic acetabular liner
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217830
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217830

Stryker Australia Pty Ltd - TRIDENT ALUMINA CERAMIC ACETABULAR INSERT - Ceramic 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

28/11/2013

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. TRIDENT ALUMINA CERAMIC ACETABULAR INSERT - Ceramic acetabular liner

Product Type

Single Device Product

Effective date

28/11/2013

GMDN

48055 Ceramic acetabular liner

Functional description

This Acetabular Insert is the inner portion of a two-piece acetabulum prosthesis that is sterile and made of

Alumina Ceramic and assembled with a Titanium Alloy Sleeve. This Acetabular Insert fits within an

Acetabular Shell, to articulate with an artificial Femoral Head as part of a Total Hip Arthroplasty (THA).

Intended purpose

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

Indications: Primary or revision total hip arthroplasty due to: Non-inflammatory degenerative arthritis

(osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, pelvic fracture, failed

fracture fixation, or diastrophic variant), or Inflammatory joint disease.

Variant information

Size D - I

Diameter (mm) Inner 28mm - 36mm

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 12:51:55 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