Device Dossier

Freeliner Alumina Composit Liner - Ceramic acetabular liner

Device Dossier for Freeliner Alumina Composit Liner - Ceramic acetabular liner (Ceramic acetabular liner, Class III, sponsor Evolutis MA). ARTG record,…

Intended purpose

Device indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medication and correctly followed conservative treatments have failed. Indications include: - Degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip) - Inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis) - Metabolic hip disease (chondrocalcinosis) - Post Traumatic degenerative arthritis - Avascular necrosis - Congenital dysplasia of the hip - Functional repair of a recent trauma (fracture, dislocation) - Revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty - Tumoral surgery when affecting the hip joint

Functional description

Freeliner Alumina Composit Liner is manufactured from alumina-zirconia ceramic by CeramTec under the name BIOLOX delta; they are available in inner diameter 32mm, 36mm and 40mm. Features include a neutral edge (no posterior wall)and a tapered external surface for the fixation in the cup.

TGA Public Summary