Device Dossier

C-TAPER TO UNIVERSAL TAPER ADAPTER SLEEVE - Femoral head/stem prosthesis adaptor

Device Dossier for C-TAPER TO UNIVERSAL TAPER ADAPTER SLEEVE - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III,…

Intended purpose

Designed to allow a Universal Taper bearing head to be used with a femoral stem with a C-taper 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 allows the fixation of a femoral head with a Universal Taper to be used with a femoral stem with a C-taper trunnion. Made of Titanium alloy (Ti6A14V).

TGA Public Summary