Search Results

The Headloc™ Ceramic Femoral Head for the Primaloc™ Cementless Hip System is intended for single-use cementless implantation during primary revision surgery. The Ceramic Head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are:

• Osteoarthritis, rheumatoid arthritis, or other osteoarthroses;
• Certain femoral neck fractures or dislocations;
• Post-traumatic arthritis:
• Idiopathic avascular necrosis of the femoral head;
• Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis;
• Previous failed surgery;
• Total hip replacement where the surgeon indicates a ceramic head

Not Found

This document is a 510(k) clearance letter from the FDA for the Headloc™ Alumina and Zirconia Ceramic Heads, dated July 9, 1997. It is a clearance for a medical device and not a study proving device performance or detailing acceptance criteria and performance against those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the provided text.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices, not a scientific report on its performance.

Ask a specific question about this device