Device Dossier

Muller Cup - Acetabular shell

Device Dossier for Muller Cup - Acetabular shell (Acetabular shell, Class III, sponsor Gruppo Bioimpianti). ARTG record, intended purpose, GMDN category…

Intended purpose

The Muller cup is intended for use in total hip arthroplasty to replace or repair the natural acetabulum. 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 Muller Cup component is designed to replace or repair the acetabulum of the patient. The MULLER prosthesis is composed by two components: a principal element made of polyethylene and a stainless steel ring as a radiologic reference. They have a hemispherical shape and are manufactured from UHMWPE. They are cemented cups, with a special grooved design on their convex external surface aimed at improving the cups primary fastening.

TGA Public Summary