Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - RHK Knee resurfacing femoral component - 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.
Biomet UK Ltd
Waterton Industrial Estate
Bridgend, South Glamorgan, CF31 3XA
1. RHK Knee resurfacing femoral component - Uncoated knee femur prosthesis
Single Device Product
32831 Uncoated knee femur prosthesis
Cobalt chrome/titanium resurfacing femoral component of the RHK totally constrained salvage knee
prosthesis. Large contact area with enhanced range of motion, maintaining full contact up to 155 degrees
of flexion. Standard size has patella (extensor) moment arm increased by 19%, with resulting improved
kinematics and more positive extension locking. Packaged with screw and intended for cemented use.
Cobalt chrome/titanium femoral 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.
Intended for cemented use.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:02:06 AEDT
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