Summary for ARTG Entry:
Zimmer Pty Ltd - NexGen® Complete Knee Solution, Rotating Hinge Knee, Articular Surface (With Hinge
Post Extension) - Prosthesis, knee, internal, insert component
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, Articular Surface (With Hinge Post Extension) -
Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
Articular surface component of the NexGen Rotating Hinge Knee 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. It is made from
Ultra-High Molecular-Weight Polyethylene, and available in multiple thicknesses to facilitate soft tissue
tensioning and joint line restoration. For cemented use only.
Articular surface component of the NexGen Rotating Hinge Knee system 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 condyle, valgus, varus, or flexion deformities, or the salvage of
previously failed surgical attempts.
Height (mm) 12-26
No Specific Conditions included on Record
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