Summary for ARTG Entry:
Zimmer Biomet Pty Ltd - Modular Head CoCr - Metallic femoral head 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. Modular Head CoCr - Metallic femoral head prosthesis
Single Device Product
33175 Metallic femoral head prosthesis
Biomet metal modular femoral heads are available with type 1 and type 12/14 tapers with various neck
lengths and are compatible with any Biomet modular femoral stem of the correct taper type. Made from
cobalt-chronium-molybdenum alloy for use with UHMW polyethylene acetabular cups and liners.
Biomet metal modular femoral heads are used in conjunction with other hip prosthesis components to form
part of a total hip joint replacement system. Indications include: Non-inflammatory degenerative joint
disease including osteoarthritis, avascular necrosis and post-traumatic arthritis. Rheumatoid arthritis.
Correction of functional deformity. Revision of failed joint reconstruction or treatment. Treatment of femoral
neck and trochanteric fractures of the proximal femur with femoral head involvement and which are
unmanageable using other techniques.
Taper Type 12/14
Size (mm) 22.2 - 32
Length (mm) -6 to +12
Taper Type 1
No Specific Conditions included on Record
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Produced at 09.11.2017 at 10:49:17 AEDT
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