Device Dossier
V40 TAPER UNIVERSAL ADAPTOR SLEEVE - Femoral head/stem prosthesis adaptor
Device Dossier for V40 TAPER UNIVERSAL 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 universal taper bearing head to be used with a femoral stem with a V40 trunnion. Indications:Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic 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. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
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 Universal Taper, allowing the fixation of a Femoral Head with a Universal Taper to a Femoral Hip Stem with a V-40 shaped Trunnion. Made of Titanium alloy (Ti6A14V)