Device Dossier

Biolox Delta Ceramic Modular Femoral Head Type 1 taper - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Ceramic Modular Femoral Head Type 1 taper - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III,…

Intended purpose

Alumina/toughened alumina femoral head type 1 taper component for use in hip joint replacement due to 1)Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post traumatic arthritis. 2)Rheumatoid arthritis. 3)Correction of functional deformity. 4)Revision of failed joint reconstruction or treatment. 5)Treatment of the femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques.

Functional description

Type 1 taper ceramic modular femoral heads are designed to be used either with ceramic acetabular inserts for ceramic on ceramic articulation, or with ultra high molecular weight polyethylene acetabular liners and cups. They may also be used with Exceed ABT M2a metal inserts for ceramic on metal articulation.

TGA Public Summary