(79 days)
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.
Not Found
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.
§ 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.