Device Dossier

Biolox Delta Ceramic Insert for FIN II Cup - Ceramic acetabular liner

Device Dossier for Biolox Delta Ceramic Insert for FIN II Cup - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Gruppo…

Intended purpose

The Biolox Delta Ceramic Insert is a sterile implantable component that is intended to be used in total hip replacement procedures to replace or repair the articulating surface of a patient’s acetabulum. The indications for the use include: - Non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - Aseptic necrosis of the femoral head - Rheumatoid Arthritis - Correction of functional deformity - Outcomes of fractures of the femoral neck - Outcomes of traumatic dislocations of the hip - Failures of osteotomy - Outcomes of arthrodesis.

Functional description

The Biolox Delta Insert component is made of ceramic and intended to be used with the FIN II acetabular cups. The Biolox Delta insert is available in the 0° (Neutral) configuration only, for use with 28mm, 32mm and 36mm femoral heads. It is inserted manually and impacted until firmly in place.

TGA Public Summary