(77 days)
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis.
The device is a single use implant intended for press-fit application.
The ReCap® HA Press-Fit Femoral Resurfacing Head is a singleuse, hemi-hip femoral resurfacing head, designed to replace the outer surface of a natural femoral head, while preserving as much natural bone as possible.
The provided document is a 510(k) summary for the ReCap® HA Press-Fit Femoral Resurfacing Head, a hemi-hip femoral prosthesis. It explicitly states that no clinical testing was required for this device as it was found substantially equivalent to a predicate device based on non-clinical testing (mechanical testing, engineering analysis, and cadaver studies) and minor modifications.
Therefore, the study design elements requested in the prompt, such as acceptance criteria, reported device performance from clinical studies, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this submission. The device's acceptance criteria were met through non-clinical methods demonstrating substantial equivalence to a legally marketed predicate device.
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.