Device Dossier

Dualis Double Mobility Cup with Plasma Spray and HA - Acetabular shell

Device Dossier for Dualis Double Mobility Cup with Plasma Spray and HA - Acetabular shell (Acetabular shell, Class III, sponsor Gruppo Bioimpianti). ARTG…

Intended purpose

Device indicated in patients with high risk of dislocation as neurological patients (Alzheimer's disease, stroke Outcomes cerebri, Dementia, Psychiatric Patients, Parkinson's disease), or hardly collaborating. The indications are tied to hip pathologies that require an arthroplasty to reduce or eliminate pain and / or improve joint function: - Non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis; - Aseptic necrosis of the femoral head; - Rheumatoid Arthritis; - Post-traumatic Arthritis; - Correction of functional deformity; - Outcomes of fractures of the femoral neck; - Outcomes of traumatic dislocations of the hip; - Failures of osteotomy; - Outcomes of arthrodesis.

Functional description

Device made of high nitrogen stainless steel and characterised by a double coating of plasma titanium spray and hydroxyapatite to guarantee secondary stability. The cup is hemispherical shaped with a 3mm cylindrical protrusion to reduce the risk of dislocation, and a gradual discharge in the lower zone to allow a greater range of motion and better follow the anatomy of the natural acetabulum. The internal surface of the cup is mirror polished to reduce insert wear.

TGA Public Summary