Device Dossier
OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated hip femur prosthesis, one-piece
Device Dossier for OMNIFIT NORMALISED CEMENTED HIP STEM (COLLARLESS) - Uncoated hip femur prosthesis, one-piece (Uncoated hip femur prosthesis,…
- GMDN category: Uncoated hip femur prosthesis, one-piece
- Sponsor: Stryker
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 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.