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The Hemisphere™ Cemented Cup is intended for single use with bone cement in primary or revision arthroplasty surgery. Indications include:

• Osteoarthritis, rheumatoid arthritis, or other osteoarthroses of the hip joint;
• Certain femoral neck fractures;
• Idiopathic avascular (osteo) necrosis;
• Post-traumatic arthritis;
• Benign or malignant bone tumors where sufficient bone is present to seat the prosthesis;
• Previously failed implant

The Hemisphere™ Cemented Cup is intended for use with the Primaloc™ Cemented Hip (K962448) and Headloc™ CoCr femoral heads (K953977), both manufactured by Ortho Development Corporation, and other commercially available hip prosthesis, which have also received FDA clearance.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the Hemisphere™ Cemented Cup. It primarily details the regulatory clearance for the device and its intended uses.

The document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of an AI/ML medical device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input. This document is a regulatory approval, not a technical performance study report.

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