Device Dossier

36mm Modular Head Co-Cr-Mo Type 1 Taper - Metallic femoral head prosthesis

Device Dossier for 36mm Modular Head Co-Cr-Mo Type 1 Taper - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor…

Intended purpose

Modular Head component of Biomet Hip System. Indications include: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision procedures where other treatment or devices have failed.

Functional description

Modular head component of Biomet hip system. 36mm diameter head with type 1 taper. Made from Co-Cr-Mo. Available with various neck offset from -6mm to +12mm.

TGA Public Summary