Device Dossier
Austral Acetabular Cup With Holes Cementless - Acetabular shell
Device Dossier for Austral Acetabular Cup With Holes Cementless - Acetabular shell (Acetabular shell, Class III, sponsor Amplitude). ARTG record,…
- GMDN category: Acetabular shell
Intended purpose
A device intended for replacement of the total hip joint in order to reduce pain and restore hip function in comparison to the preoperative status and intended to be used in primary replacement for total hip arthroplasty. The device is indicated for use as a component of a total hip replacement for the relief of pain and significant disability in case of: - Primitive and secondary hip osteoarthritis; - Aseptic osteonecrosis; - Rheumatoid arthritis/inflammatory diseases; - Hip and acetabular fracture; - Hip joint arthroplasty when other devices or treatments have failed.
Functional description
The device is manufactured from high strength titanium alloy. To provide optimum press fit fixation and bone in-growth, the outer surface is covered with an asymmetric sintered titanium coating of high porosity. The cup shells have a centred apical hole (sealable post-operatively) for cup insertion and 3 holes around the circumference to allow better initial fixation of the shell if required. Factory installed screw hole covers provide a complete seal to prevent debris migration.