Device Dossier

OMNIFIT CEMENTED LONG HIP STEM - Uncoated hip femur prosthesis, modular

Device Dossier for OMNIFIT CEMENTED LONG HIP STEM - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor…

Intended purpose

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 results.

Functional description

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.

TGA Public Summary