Summary for ARTG Entry:
Zimmer Pty Ltd - NexGen® Complete Knee Solution Legacy® Knee LPS-Flex Gender Solutions™ Female
(GSF) Femoral Component Option - 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. NexGen® Complete Knee Solution Legacy® Knee LPS-Flex Gender Solutions™ Female (GSF) Femoral
Component Option - Prosthesis, inter - Uncoated knee femur prosthesis
Single Device Product
32831 Uncoated knee femur prosthesis
Femoral component designed to address specific anatomic features of the distal femur that can be seen in
both male and female patients, but are more typical of a female patient. An extended posterior condyle
radius provides greater tibio-femoral contact area in deep flexion which reduces the possibility of point
loading as flexion approaches 155°. Manufactured from Zimaloy® Cobalt-Chromium-Molybdenum alloy.
For cemented use only.
Indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle.
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or
prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical
attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
No Specific Conditions included on Record
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