Summary for ARTG Entry:
Stryker Australia Pty Ltd - OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated
hip femur prosthesis, one-piece
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. OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated hip femur prosthesis, one-piece
Single Device Product
34223 Uncoated hip femur prosthesis, one-piece
A sterile implantable one piece Femoral Hip Stem designed to replace the proximal femoral neck as part of
a Hip Arthroplasty. Intraoperatively assembled with a Femoral Head with a C-taper or a C-taper extension
is required. Made of Cobalt Chrome and intended for use with cement.
A component of a total hip joint prosthesis that is used to replace the femoral neck.
For use as a Bipolar Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the
femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular
involvement or distortion.
Other Considerations: Pathological conditions or age considerations which indicate a more conservative
acetabular procedure and an avoidance of the use of bone cement in the acetabulum. Salvage of failed
total hip arthroplasty.
For use as a Total Hip Replacement: Painful, disabling joint disease of the hip resulting from: degenerative
arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis. Revision of previous
unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management
problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory
Diameter (mm) Distal Stem 8.1 - 16.0
Length (mm) Stem 100 - 170
No Specific Conditions included on Record
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