(121 days)
- Fractures of the proximal femur.
- Non-unions of proximal femoral neck fractures.
- Aseptic necrosis of the femoral head.
- Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum.
- Salvage of failed total hip arthroplasty.
ARGOMEDICAL Biopolar Hip System
I am sorry, but the provided text is a letter from the FDA regarding the substantial equivalence of the ARGOMEDICAL Bipolar Hip System to a predicate device. It does not contain information about acceptance criteria, device performance metrics, study design, or expert adjudication that would be needed to answer your request. Therefore, I cannot generate the requested table and descriptions based on this information.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.