Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service
Kit - Rotating hinged total knee 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. NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit - Rotating hinged total
Single Device Product
33692 Rotating hinged total knee prosthesis
The NexGen® Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit is comprised of
the NexGen Rotating Hinge Knee polyethylene box insert, one-piece hinge post, CoCrMo hinge pin, hinge
pin plug and tibial bushing. It is designed to allow the replacement or servicing of the NexGen Rotating
Hinge Knee Articular Surface or Segmental Articular Surface and the modular hinge post in situ without
disrupting the fixation of the femoral and tibial components.
The NexGen Complete Knee Solution Rotating Hinge Knee Femoral Hinge Service Kit is a component of
the NexGen® Rotating Hinge Knee (RH Knee) which is designed for revision, difficult primary, and limb
salvage surgeries in patients with significant bone loss and/or ligament deficiencies.
Indicated for patients with:
± Moderate 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
± Valgus, varus, or flexion deformities.
± The salvage of previously failed surgical attempts.
No Specific Conditions included on Record
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