Summary for ARTG Entry:
Stryker Australia Pty Ltd - OMNIFIT CEMENTED LONG HIP STEM - Revision uncoated femoral stem
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 CEMENTED LONG HIP STEM - Revision uncoated femoral stem prosthesis
Single Device Product
34038 Revision uncoated femoral stem prosthesis
A sterile implantable modular Femoral Hip Stem designed to replace the proximal femoral neck as part of
a Total Hip Arthroplasty (THA). Designed for a compatible Femoral Head to be attached and to articulate
with an appropriate Acetabular Component as part of a Total Hip Arthroplasty (THA). 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
Length (mm) Neck 25mm - 40mm
Length (mm) Stem 200mm - 350mm
Diameter (mm) Distal 10.9mm - 15.5mm
No Specific Conditions included on Record
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