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The Rim-Fix, acetabular cup system is intended to be used as the pelvic component of a total hip arthroplasty. It can be implanted either as a press fit cup or cemented into the cavity. The acetabular cup is used to restore the acetabular cavity in a total joint arthroplasty and is used in conjunction with a metal femoral hip stem. The indications for use of the Rim-Fix cup system are as follows: Osteoarthritis, rheumatoid arthritis, posttraumatic arthritis or arthritis secondary to a variety of diseases or anomalies, or revision from a failed arthroplasty.

Rim-Fix, Acetabular Cup

The provided FDA document is a 510(k) clearance letter for a medical device called the "Rim-Fix, Acetabular Cup System." This document primarily addresses the regulatory approval of the device based on substantial equivalence to a predicate device.

It does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance, as these concepts are typically associated with the evaluation of AI/ML-driven medical devices or diagnostic tools.

The document is for a traditional medical implant (an acetabular cup for total hip arthroplasty), and its approval process would have focused on engineering specifications, biocompatibility, mechanical testing (e.g., fatigue, wear), and clinical equivalence to existing, legally marketed devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is not present.

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