Summary for ARTG Entry:
Zimmer Pty Ltd - NexGen® Complete Knee Solution Rotating Hinge Knee (RHK), 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 Rotating Hinge Knee (RHK), Femoral Component, Option - Uncoated
knee femur prosthesis
Single Device Product
32831 Uncoated knee femur prosthesis
Femoral 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. Manufactured
from Zimaloy® Cobalt-Chromium-Molybdenum alloy. For cemented use only.
Femoral component of the NexGen Rotating Hinge Knee prosthesis system intended 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, the salvage of
previously failed surgical attempts.
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 04:15:16 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information