Device Dossier
OXINIUM Modular Femoral Heads - Ceramic femoral head prosthesis
Device Dossier for OXINIUM Modular Femoral Heads - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Smith & Nephew).…
- GMDN category: Ceramic 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 artificial femoral head that has an oxidized zirconium ceramic surface and is designed to mate with a titanium taper sleeve and articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. Modular heads are designed to fit on any Smith & Nephew femoral stem. The taper sleeve is firmly placed on the taper and the modular head is placed on the sleeve and impacted with a mallet.