Device Dossier

FIXA DUPLEX Dual Mobility Cemented Cup - Acetabular shell

Device Dossier for FIXA DUPLEX Dual Mobility Cemented Cup - Acetabular shell (Acetabular shell, Class III, sponsor Adler Ortho). ARTG record, intended…

Intended purpose

A sterile implantable acetabular component of a total hip prosthesis designed to replace the articulating surfaces of the hip in conjunction with a bipolar insert. To be used with bone cement. Indicated for; - Primary and secondary arthrosis - Rheumatoid and degenerative arthritis - Deformities, such as dysplasia - Fractures and necrosis of bone - Revisions, where other devices or treatments have failed - Metastatic diseases

Functional description

The metal cup is manufactured from M30NW stainless steel; the exterior surface is designed to maximise contact with the cement. Compatible with CoCrMo or ceramic heads with diameters of 22.2 mm (all sizes) or 28 mm (from size 48 upwards). Hemispherical with an additional cylindrical 3 mm band. The interior of the Fixa Duplex cup has a mirror finish to minimise any wear to the mobile polyethylene insert.

TGA Public Summary