Device Dossier

BIOLOX delta cup insert - Ceramic acetabular liner

Device Dossier for BIOLOX delta cup insert - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Life Healthcare). ARTG record,…

Intended purpose

A ceramic cup insert component used with a cementless acetabular cup as part of the primary operation of the hip joint impaired by conditions such as arthrosis, rheumatoid arthritis, femoral neck fractures, avascular necrosis, or hip dysplasia.

Functional description

Acetabular cup insert comprised of Al2O3 and ZrO3 ceramic. Fits into a suitable acetabular shell and is designed to be used in conjunction with a Biolox Delta head providing articulation between a ceramic femoral head and acetabular liner.

TGA Public Summary