Device Dossier

ic-bipolar Head CoCrMo - Femoral head bipolar component

Device Dossier for ic-bipolar Head CoCrMo - Femoral head bipolar component (Femoral head bipolar component, Class III, sponsor Life Healthcare). ARTG…

Intended purpose

A bipolar femoral head component used as part of hemiarthroplasty. The main indications for the insertion of a hemi arthroplasty implant: - femoral neck fractures, - femoral head necrosis.

Functional description

ic-bipolar heads/bipolar heads (Material: Inner shell and retainment ring UHMW-PE, Outer Shell: CoCrMo casting alloy. These heads articulate directly with the cartilage of the non-prepared acetabulum. They are matched with an IC titanium, IC CrCoMo or Biolox forte/delta ceramic femoral head that seats within the bipolar head and this head is then attached to a trunion of a femoral stem.

TGA Public Summary