Device Dossier
MultiPolar® Bipolar Cup, Shell - Femoral head bipolar component
Device Dossier for MultiPolar® Bipolar Cup, Shell - Femoral head bipolar component (Femoral head bipolar component, Class III, sponsor Zimmer Biomet).…
- GMDN category: Femoral head bipolar component
Intended purpose
The MultiPolar® Bipolar Shell is indicated for use in: Fracture dislocation of the hip; Elderly, debilitated patients when a total hip replacement is contraindicated; Irreducible fractures in which adequate fixation cannot be obtained; Certain high subcapital fractures and comminuted femoral neck fractures in the aged; Nonunion of femoral neck fractures; Secondary avascular necrosis of the femoral head; Pathological fractures of the femoral neck; Osteoarthritis in which the femoral head is primarily affected.
Functional description
The outer shell component of the MultiPolar® Bipolar Cup. Made from Zimaloy® Cobalt-Chromium-Molybdenum Alloy. The Zimaloy® Alloy shell contains a Tivanium® Ti-6Al-4V Alloy retaining ring which locks the UHMWPE liner inside the shell. To provide surgical latitude, a variety of both inner and outer diameter sizes are available.