Summary for ARTG Entry:
Zimmer Pty Ltd - RHK knee rotating tibial bearing - 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.
Biomet UK Ltd
Waterton Industrial Estate
Bridgend, South Glamorgan, CF31 3XA
1. RHK knee rotating tibial bearing - Prosthesis, knee, internal, insert component
Single Device Product
46585 Prosthesis, knee, internal, insert component
Bi-helical design Arcom rotating bearing which articulates on the highly polished cobalt chrome tibial tray.
Large femoral contact area with enhanced range of motion, maintaining full contact up to 155 degrees of
Arcom tibial bearing component of the Rotating Hinge Knee salvage knee prosthesis. Indications for use
include: significant bone loss; gross ligamentous deficiencies; oncological bone replacement (primary or
metastatic); salvage knee arthroplasty; trauma; connective tissue disorders.
Size For 63-67MM tray
Size For 71-75MM tray
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 09.11.2017 at 09:52:50 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