Device Dossier

PE-Cup Mueller II cemented - Polyethylene acetabulum prosthesis

Device Dossier for PE-Cup Mueller II cemented - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor Life…

Intended purpose

The Mueller II All Poly Cup is a hemi-spherical all polyethylene monoblock acetabular cup for the replacement of a diseased acetabulum. It represents the articulating surface of a total hip replacement and is to be combined with a modular head of a respective hip stem. The cup can be used for various indications, such as degenerative or rheumatoid arthritis, femoral neck fractures or avascular necrosis and hip dysplasia. Other indications include post-operative conditions after previous surgery with or without the use of implants. In cases of deficient bone quality or bone stock the Mueller II All Poly Cup can be combined with acetabular cages or rings.

Functional description

Comprised of ultra-high molecular weight polyethylene (UHMWPE) for cemented fixation. Represents the articulating surface of a total hip replacement to be combined with a modular head of a respective hip stem. The cup has circumferential circular grooves to enhance tilt stability and cement compression and 6 equally spaced radial grooves to provide rotational stability. A wire x-ray marker of stainless steel is snap fit into a groove in the equatorial region of the cup.

TGA Public Summary