Capitole C Cemented Dual Mobility Acetabular Cup - Metallic acetabulum prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Evolutis MA Australia Pty Ltd

Class:

Class III

Manufactured by:

Evolutis SAS Avenue de la Liberation, Briennon, F-42720 France

Therapeutic area:

60516 - Metallic acetabulum prosthesis

Therapeutic indications:

The CAPITOLE C cemented dual mobility cup is made from stainless steel intended to be cemented into the acetabulum. A removable mobile polyethylene liner is intended to be articulated with a constrained joint with a ball head of a femoral prosthesis. It may be used in association with cemented or cementless femoral stems and 22.2 or 28mm femoral head manufactured by Evolutis. 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 medicamentation and correctly followed conservative treatment have failed. For the patient, his anatomy and the structure of his articulation will need to be adapted to receive the selected implant(s). Indications for total or partial hip arthroplasty are: - 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. The recommended indications for dual mobility cup are: - Primary arthroplasties for patients at high risk of dislocation (severe neurological affliction, neuropsychiatric disorders, addictions and severe neuromuscular deficiencies), - Revision arthroplasties in cases of recurrent dislocations for patients at high risk of articular instability.

Authorization status:

A

Authorization date:

2021-08-25