Device Dossier

Fin II Cup with HA - Acetabular shell

Device Dossier for Fin II Cup with HA - Acetabular shell (Acetabular shell, Class III, sponsor Gruppo Bioimpianti). ARTG record, intended purpose, GMDN…

Intended purpose

The Fin II Cup is a sterile implantable principal component of acetabular component and is intended for use in total hip arthroplasty. The indications for the use include: - Non-inflammatory degenerative joint disease such as primary or secondary osteoarthritis, - Aseptic necrosis of the femoral head - Rheumatoid 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

The Fin II Cup component is designed to replace or repair the acetabulum of the patient. The hemispherical shape allows global contact between cup and acetabular bone. The Fin II Cup with HA is manufactured in titanium alloy metal (Ti6Al4V) and used with a polyethylene, ceramic, or CoCr alloy insert liner.

TGA Public Summary