Summary for ARTG Entry:
Stryker Australia Pty Ltd - MRH Tibial Bearing Component (Reverse Crossover) - Rotating hinged total
ARTG entry for
Medical Device Included Class III
Stryker Australia Pty Ltd
PO Box 970,ARTARMON, NSW, 1570
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.
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah, New Jersey, 07430
United States Of America
1. MRH Tibial Bearing Component (Reverse Crossover) - Rotating hinged total knee prosthesis
Single Device Product
33692 Rotating hinged total knee prosthesis
This Tibial Bearing component is assembled intraoperatively with a set of bushings and an axle, a bumper
locks this assembly (supplied separately). This assembly provides motion through the axle/bushing
combination in the flexion/extension plane. The stem of the tibial bearing component fits into the
polyethylene tibial component or insert which is fixed to the tibia, providing motion in the rotational plane
and translation in the axial plane. Made from forged VITALLIUM Alloy.
A tibial bearing component of a Modular Rotating Hinge Knee System, intended to be implanted in the
1. There is destruction of the joint surfaces, with or without significant bone deformity.
2. The cruciate and/or collateral ligaments do not stabilize the knee joint.
3. The ligaments are inadequate and/or the musculature is weak. And/or,
4. Revision is required of a failed prostheses where there has been gross instability, with or without bone
loss or inadequate soft tissue
Nil variant (as 1 device) Nil
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 09:38:24 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