Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Maxim Knee System Biomet finned primary modular stem 40X46MM - 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 PO Box 587
Warsaw, IN, 46581
United States Of America
1. Maxim Knee System Biomet finned primary modular stem 40X46MM - Uncoated knee tibia prosthesis,
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
Titanium alloy 46 X 40 MM modular finned stem. For use with Biomet modular tibial trays; packaged with
screw. The combination of a Morse-type taper and screw fixation helps maintain a solid connection
between the stem and baseplate. When more fixation is desired, the stemmed or offset tray will accept a
40, 80, 120, 160, or 200 mm stem extension.
Titanium alloy finned primary tibial stem. Indications for use include: Painful and disabled knee joint
resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are
involved; Correction of varus, valgus, or post-traumatic deformity; Correction or revision of unsuccessful
osteotomy, arthrodesis, or failure of previous joint replacement procedure
Nil variant (as 1 device) Nil
No Specific Conditions included on Record
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Produced at 03.11.2017 at 04:22:15 AEDT
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