Main information

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



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

Other information


  • 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:


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

ARTG entry for

Medical Device Included Class III


Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Zimmer Trabecular Metal Technology Inc

10 Pomeroy Road

Parsippany, NJ, 07054

United States Of America


1. Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis

Product Type

Single Device Product

Effective date



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


· 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

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.

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