Device Dossier

Freeliner Ti+HA Press-fit Cup Non Cemented - Metallic acetabulum prosthesis

Device Dossier for Freeliner Ti+HA Press-fit Cup Non Cemented - Metallic acetabulum prosthesis (Metallic acetabulum prosthesis, Class III, sponsor…

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

The Freeliner Ti+HA Press-fit Cup is manufactured from titanium alloy. There is a coating on the external side of the cup of dual coating titanium and hydroxyapatite. The cup includes 4 screw holes, an 18° Morse taper with a micro-threaded surface for ceramic insert fixation, a clipping lip below or above the tapered connection for UHMWPE insert fixation and recesses for the orientation of anti dislocation wall and the rotational resistance of the UHMWPE insert.

TGA Public Summary