Summary for ARTG Entry:
Zimmer Pty Ltd - NexGen® Complete Knee Solution Rotating Hinge Knee Tibial Component, Precoat -
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.
1800 West Center Street
WARSAW, INDIANA, 46580
United States Of America
1. NexGen® Complete Knee Solution Rotating Hinge Knee Tibial Component, Precoat - Uncoated knee tibia
Single Device Product
32832 Uncoated knee tibia prosthesis, metallic
Modular Tibial component of the NexGen Rotating Hinge Knee prosthesis system intended for
flexion/extension and internal/external rotation between the femoral and tibial components, but is
constrained in the anterior/posterior and medial/lateral directions by means of a femoral hinge post
extension. Tibial components are made from Zimaloy® Cobalt-Chromium-Molybdenum alloyand are for
cemented use only.
Tibial component of the NexGen Rotating Hinge Knee prosthesis system intended to repair or replace the
tibial knee joint, for patients with mderate to severe knee instability, significant bone loss and/or ligament
deficiencies caused by neoplasms, trauma, rheumatoid arthritis, osteoarthritis, traumatic arthritis,
polyarthritis, collagen disorders, and/or avascular necrosis of the femoral condyle, valgus, varus, or flexion
deformities, the salvage of previously failed surgical attempts.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:15:00 AEDT
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