Device Dossier

T.O.P Acetabular Metal Casing, HX coating, Cementless - Acetabular shell

Device Dossier for T.O.P Acetabular Metal Casing, HX coating, Cementless - Acetabular shell (Acetabular shell, Class III, sponsor Link Orthopaedics).…

Intended purpose

Metal casing acetabular shell component of the TOP Acetabular Cup system indicated for use in 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

The metal casing is made of titanium alloy with a coating of HX(Calcium phosphate) and is for cementless fixation. It is pre-drilled with holes for additional screw fixation and includes 2 peep-hole locking screws and 4 screw-hole plugs. It is coupled with a polyethylene insert by snap lock mechanism

TGA Public Summary