Trabecular

Main information

  • Trade name:
  • Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216639
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216639

Zimmer Pty Ltd - Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis

ARTG entry for

Medical Device Included Class III

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

28/10/2013

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

Zimmer Trabecular Metal Technology Inc

10 Pomeroy Road

Parsippany, NJ, 07054

United States Of America

Products

1. Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis

Product Type

Single Device Product

Effective date

28/10/2013

GMDN

35661 Acetabulum prosthesis

Functional description

The Trabecular Metal Revision Acetabular Shells have an elliptical geometry and are manufactured from

Trabecular Metal with a titanium alloy face ring and dome screwholes. They are intended for use with a

cemented Replacement UHMWPE liner.

Intended purpose

Trabecular Metal Revision Acetabular Shells are indicated for:

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

rheumatoid arthritis or late stage avascular necrosis.

· Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other

procedure.

· Clinical management problem where arthrodesis or alternative reconstruction 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

Size (mm) (48-80) Cup Size

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 04:39:49 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