Device Dossier
Austral Cross-Linked Polyethylene Liner - Non-constrained polyethylene acetabular liner
Device Dossier for Austral Cross-Linked Polyethylene Liner - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular…
- GMDN category: Non-constrained polyethylene acetabular liner
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 a modular, advanced bearing surface liner, composed of Amplitude highly cross-linked polyethylene, that minimizes wear and increases durability. High tolerance machining and a stable liner locking mechanism provide ease in liner insertion and reduces the potential for wear and particulate debris generation at the cup-liner interface. The acetabular systems feature a cross-linked UHMWPE bearings with a 20° hooded and neutral options.