C2 Cross-Linked Polyethylene Liner - Non-constrained polyethylene acetabular liner

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Amplitude Australia Pty Ltd

Class:

Class III

Manufactured by:

Amplitude 11 Cours Jacques Offenbach ZA Mozart 2, Valence, 26000 France

Therapeutic area:

43168 - Non-constrained polyethylene acetabular liner

Therapeutic indications:

The C2 liner is a modular, advanced bearing surface liner, composed of highly cross-linked polyethylene, that minimises 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 C2 cups are the components of a total hip prosthesis. They are intended to be used in primary replacement for total hip arthroplasty and indicated for hip arthroplasty in order to reduce pain and significant disability in cases 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.

Authorization status:

A

Authorization date:

2021-11-27