Device Dossier
Stainless Steel 12/14 Taper Femoral Head - Metallic femoral head prosthesis
Device Dossier for Stainless Steel 12/14 Taper Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor…
- GMDN category: Metallic femoral head prosthesis
- Sponsor: Smith & Nephew
Intended purpose
Femoral Heads are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Femoral Heads are indicated for individuals for inflammatory degenerative joint disease including rheumatoid arthritis; congenital dysplasia; femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and fracture dislocation of the hip.
Functional description
A sterile implantable stainless steel femoral head offered in various sizes with built-in neck offset adjustments to better match patient needs. It is designed to mate with a stainless steel femoral stem through a corresponding 12/14 taper. The device is designed to articulate with a polyethylene liner and is impacted onto the femoral stem with a mallet.