(49 days)
The R120™ Modular Total Hip System is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Total Hip System is intended for use with and without bone cement.
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The provided text is an FDA 510(k) clearance letter for a medical device (R120™ Modular Total Hip System - Line Extension). It does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.
The document primarily focuses on:
- Confirming that the device is substantially equivalent to legally marketed predicate devices.
- Outlining the regulatory classification and general controls applicable to the device.
- Stating the intended indications for use.
Therefore, I cannot provide the requested information based on the input text. The text does not detail any performance studies, test sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.