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The BOFOR Revision Cup is intended to be used to replace the acetabulum in revision hip arthroplasty.

The BOFOR Revision Cup consists of a titanium shell (Ti 6Al 4V) and an UHMWPE insert with a pure titanium cover shell. The BOFOR cup is asymmetrical and elongated, giving it a slightly "bean-shaped" design. This bean shape gives better three-point anchorage and provides better protection for the posterior column of the acetabulum. Other features of the BOFOR cup include a decentralized acetabulum inlay, cancellous bone screw anchorage, external fixation ribs, and a cranial keel, which acts as an adjuvant support column. The BOFOR cup comes in six sizes with compatible PE inserts in three sizes.

This document is a 510(k) summary for the BOFOR Revision Cup, a medical device intended for revision hip arthroplasty. The provided text primarily establishes substantial equivalence to predicate devices and outlines the device's characteristics, indications, and contraindications. It does not contain the detailed information requested regarding specific acceptance criteria, a study demonstrating performance against those criteria, or the methodology of such a study (sample size, ground truth, expert qualifications, etc.).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document mentions "Biomechanical Testing has been provided. All test results are sufficient for in vivo loading," but it does not elaborate on what these tests were, what their acceptance criteria were, or the performance metrics achieved.

To answer your request, a document detailing the specific performance studies (e.g., mechanical testing protocols, fatigue testing, wear resistance tests) and their results would be necessary.

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