Summary for ARTG Entry:
Smith & Nephew Pty Ltdy Ltd - PROSTHESIS Fracture Head (CoCrMo) - Metallic femoral head prosthesis
ARTG entry for
Medical Device Included Class III
Smith & Nephew Pty Ltd
PO Box 393, North Ryde, NSW, 1670
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.
Smith & Nephew Orthopaedics AG
Baar, , 6340
1. PROSTHESIS Fracture Head (CoCrMo) - Metallic femoral head prosthesis
Single Device Product
33175 Metallic femoral head prosthesis
A femoral head component that articulates against the acetabulum in hemiarthroplasty procedures. The
highly polished CoCrMo surface minimizes friction between the implant and acetabulum and the standard
12/14 taper allows for various stem options. Following femoral head removal, the femoral canal is
prepared and the femoral component is implanted. The fracture head is permanently fixed onto the femoral
component with a plastic hammer following trial reduction.
A sterile femoral head component of a partial hip system. The fracture head is intended to be used for the
·Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
·Fracture or avascular necrosis of the femoral head
·Conditions resulting from previous operations, such as osseosynthesis, joint reconstruction, arthrodesis,
hemiarthroplasty or hip total prosthesis.
The Prosthesis Fracture Head is made from CoCrMo and should not be combined with stainless steel
Size Small - Medium
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:24:59 AEDT
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