Device Dossier

Cemented Korus Stem - Uncoated femoral stem prosthesis, one-piece

Device Dossier for Cemented Korus Stem - Uncoated femoral stem prosthesis, one-piece (Uncoated femoral stem prosthesis, one-piece, Class III, sponsor…

Intended purpose

Intended to replace the proximal femoral neck as part of a total hip arthroplasty. The indications are tied to hip pathologies that require an arthroplasty to reduce or eliminate pain and / or improve joint function. The general guidelines are: 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 and Outcomes of arthrodesis.

Functional description

Cemented Korus is a straight femoral stem realized in high nitrogen stainless steel alloy with a mirror polished surface finish that minimises abrasion of the cement. It is available with 2 different CCD angles. The stem has a standard 12/14 Morse cone which allows the use of ceramic, CoCrMo alloy and high-nitrogen stainless steel heads. Implantation is intended to be performed with bone cement.

TGA Public Summary