Device Dossier
BIOLOX Delta Ceramic Femoral Heads 12/14 taper - Ceramic femoral head prosthesis
Device Dossier for BIOLOX Delta Ceramic Femoral Heads 12/14 taper - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor…
- GMDN category: Ceramic femoral head prosthesis
Intended purpose
A total hip system component used to replace the femoral head in total hip arthroplasty. Indications include use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture; 3) revision procedures where other treatments or devices have failed.
Functional description
Composed of alumina matrix composite, the ceramic femoral head is designed to articulate with Dynasty A Class Poly (UHMWPE) liners.