Device Dossier

Biolox Delta Ceramic Liner - Ceramic acetabular liner

Device Dossier for Biolox Delta Ceramic Liner - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Medacta). ARTG record, intended…

Intended purpose

The BIOLOX delta insert is fitted directly into a metal acetabular shell in total hip joint replacement surgery. Indications for use include, severly painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis, or congenial hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failure of previous hip surgery; joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.

Functional description

The BIOLOX delta insert is manufactured from high-purity alumina ceramic compound. The insert is fitted directly into a metal acetabular shell. The external diameter of the liner will be the same as the internal diameter of the acetabular shell implanted following the letter code; the internal diameter of the liner will be the same as the head chosen. The BIOLOX delta insert can be used together with any BIOLOX delta or BIOLOX forte femoral head of suitable head diameter.

TGA Public Summary