Device Dossier

Biolox Delta Ceramic Femoral Head - Ceramic femoral head prosthesis

Device Dossier for Biolox Delta Ceramic Femoral Head - Ceramic femoral head prosthesis (Ceramic femoral head prosthesis, Class III, sponsor Gruppo…

Intended purpose

The Biolox Delta Ceramic Femoral Head is a sterile implantable component of the Gruppo Hip System and is intended to replace the femoral head in total hip arthroplasty procedures. The indications for 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 Femoral Heads are made of ceramic and are intended to be used with prosthetic femoral stems. The femoral heads are available in three head diameter sizes (28mm, 32mm, 36mm), each with a 12/14 Morse taper of four different insert depths so as to axially shift the centre of rotation by -3.5mm, 0mm, +3.5mm, or +7.0mm.

TGA Public Summary