Search Results

The Contemporary Acetabular Component is intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This component is designed to be cemented into the acetabulum.

The Contemporary Acetabular Component is a polyethylene cup that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. The Contemporary Acetabular Component is available in outer diameters of 38 to 80mm in two millimeter increments. These cups are manufactured from Ultra High Molecular Weight Polyethylene which conforms to ASTM F-648.

The provided text is a 510(k) summary for the Contemporary Acetabular Component, a medical device for hip replacement. It outlines the device description, intended use, and claims of substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study proving the device meets said criteria, as is common for many 510(k) submissions that rely on predicate device equivalence.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on demonstrating equivalence, not on specific performance acceptance criteria or a study proving those criteria were met for this particular device.

Ask a specific question about this device