Summary for ARTG Entry:
Zimmer Pty Ltd - Zimmer® Unicompartmental Knee System, Femoral Component, High Flex Precoat -
Uncoated knee femur 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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. Zimmer® Unicompartmental Knee System, Femoral Component, High Flex Precoat - Uncoated knee femur
Single Device Product
32831 Uncoated knee femur prosthesis
Designed for the surface reconstruction of individual femoral condyles and made from Zimaloy®
Cobalt-Chromium-Molybdenum Alloy and are for cemented use only.
Femoral component of the Zimmer® Unicompartmental Knee System prosthesis indicated for patients
- Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
- Previous tibial condyle or plateau fractures with loss of anatomy or function.
- Varus or valgus deformities.
- Revision of previous arthroplasty procedures.
Shape Left Medial/Right Lateral
Shape Right Medial/Left Lateral
No Specific Conditions included on Record
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Produced at 10.11.2017 at 05:03:27 AEDT
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