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
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class III
- 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
Single Device Product
35661 Acetabulum prosthesis
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.
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.
Size (mm) (48-80) Cup Size
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:39:49 AEDT
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