Device Dossier

Link IP UHMWPE Acetabular Cup - Polyethylene acetabulum prosthesis

Device Dossier for Link IP UHMWPE Acetabular Cup - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor Link…

Intended purpose

Polyethylene Acetabular Cup system indicated for cementable fixation in the acetabulum in the treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures • Primary and secondary coxarthrosis • Osteoarthritis • Necrosis of the femoral head • Femoral neck fractures • Revision after implant loosening

Functional description

Functional description to: The polyethylene acetabular cup implant for cementable fixation in the acetabulum used in primary hip arthroplasty. Polyethylene acetabular cups are supplied with X-ray markers for easy location on the X-ray and are suitable for use with ceramic or CoCrMo heads with Integrated spacers on external profile to give homogeneous cement mantle. The edge of the acetabular cup is bevelled towards the inside to improve the range of movement of the prosthesis in the cup.

TGA Public Summary