Device Dossier
SIW Modular Femoral Head - Metallic femoral head prosthesis
Device Dossier for SIW Modular Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Stryker). ARTG…
- GMDN category: Metallic femoral head prosthesis
- Sponsor: Stryker
Intended purpose
The Modular Femoral Head is used in conjunction with the METS Proximal femur and METS Total femur systems in Total Joint Arthroplasty. Indications: - Limb salvage procedures where radical resection and replacement of the bone is required - Tumor resections - Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques - Revision of previously failed total joint arthroplasty.
Functional description
A sterile implantable ball-shaped component intend to replace the femoral head. With an inner taper of 12/14, it is intended to fit on the trunnion of a trochanteric component and articulate with an acetabular component. Comes in a range of diameters and offsets to reconstruct the patient’s joint. Made of Cobalt Chromium.