Device Dossier

CoCr Metal Femoral Head 12/14 - Metallic femoral head prosthesis

Device Dossier for CoCr Metal Femoral Head 12/14 - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Amplitude).…

Intended purpose

AMPLITUDE femoral heads are intended for being used as femoral components for replacement of the total hip joint in order to reduce pain and restore hip function in comparison with preoperative status. They need to be associated to femoral stem and acetabular implant. They are indicated in case of hip arthroplasty for the relief of pain and significant disability following: - Traumatic injury or non-inflammatory degenerative joint disease of the hip with diagnosis of: - Proximal femoral fracture; - Acetabular fracture; - Non-union of a previously treated fracture; - Osteoarthritis; - Traumatic arthritis; - Avascular necrosis or slipped capital epiphysis; - Rheumatoid arthritis/inflammatory diseases. Metal femoral heads are also suitable for the revision of hip prostheses and for joint reconstruction.

Functional description

Cobalt chrome alloy femoral heads are available in multiple neck lengths for proper anatomic fit. Heads are highly polished for reduced friction and wear. In revision surgery, the state of the stem neck and the metalback must be assessed. Deteriorations such as scratches may have an impact on the functionality and/or stability of the prosthesis. CoCr femoral heads can only be combined with polyethylene (PE) liners or acetabular components.

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