Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Biomet Offset Tibial tray - Uncoated knee tibia prosthesis, metallic
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.
56 East Bell Drive
Warsaw, IN, 46581
United States Of America
1. Biomet Offset Tibial tray - Uncoated knee tibia prosthesis, metallic
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
Titanium alloy offset tibial baseplate. Designed for assembly with appropriate offset stem adapter (neutral,
2.5MM or 5MM), and locking components. Packaged with locking bar and plugs.
Offset titanium alloy tibial tray component for use in knee joint replacement due to
1) painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis
where one or more compartments are involved
2) correction of varus, valgus, or posttraumatic deformity
3) correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement
Size (mm) 59-91
No Specific Conditions included on Record
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