Device Dossier

Cross-linked PE Standards Inserts ESOP (ATLAS) Trianon - Acetabular shell

Device Dossier for Cross-linked PE Standards Inserts ESOP (ATLAS) Trianon - Acetabular shell (Acetabular shell, Class III, sponsor Perios). ARTG record,…

Intended purpose

The insert a component of the ATLAS system is intended for Primary, dysplasic or protruding coxarthrosis; Rheumatoid coxitis; Coxarthrosis with necrosis of the femoral head; Revision surgery in a septic or aseptic environment; Congenital dislocation; Traumatic injuries; Femoral neck fracture and Osteonecrosis of the femoral head.

Functional description

A cross-linked polyethylene insert designed to reduce ware and as a result retard the onset of osteolysis. The device should be used only with an alumina head or a CoCr metal head but not with a stainless steel head.

TGA Public Summary