Device Dossier
V40 / C-TAPER ADAPTOR SLEEVE - Femoral head/stem prosthesis adaptor
Device Dossier for V40 / C-TAPER ADAPTOR SLEEVE - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor…
- GMDN category: Femoral head/stem prosthesis adaptor
- Sponsor: Stryker
Intended purpose
Designed to allow a C-taper bearing head to be used with a femoral stem with a V40 taper trunnion. Indication: 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 Adapter Sleeve, fitted intraoperatively to the trunnion of a Femoral Hip Stem. The adaptor sleeve provides for the proper fixation and mechanical function of a C-Taper, allowing the fixation of a Femoral Head with a C-Taper to a Femoral Hip Stem with a V-40 shaped trunnion. Made of Titanium alloy (Ti6Al4V)