Device Dossier

Biolox Delta Option Ceramic Femoral Head 16/18 taper - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Option Ceramic Femoral Head 16/18 taper - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III,…

Intended purpose

Biolox delta Option ceramic modular head components are indicated for use either with ceramic acetabular inserts for ceramic on ceramic articulation or with Biomet’s range of 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. Indications for use include: 1. Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and post-traumatic arthritis. 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 by other techniques. 5. Revision procedures where other devices or treatments have failed.

Functional description

Biolox Delta Option ceramic modular head components are comprised of a Transition-Toughened-Platelet Alumina composite ceramic (TTPA) material with a highly polished surface available in a variety of head sizes. The highly polished surface is designed to reduce friction and minimize wear. The Biolox Delta option femoral head component mates with the titanium alloy Type 1 or Type 12/14 neck sleeve taper adaptor for both primary and revision total hip arthroplasty

TGA Public Summary