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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

The Headloc™ Ceramic Head may be used with the Primaloc™ Cemetless Hip System which is cleared for use under Premarket Notification K953977.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Headloc™ Ceramic Femoral Head." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The information provided in this document is primarily:

• Device Name: Headloc™ Ceramic Femoral Head
• Manufacturer: Ortho Development Corporation
• Regulatory Class: II
• Product Codes: LZO
• 510(k) Number: K970675
• Date of Clearance: August 22, 1997
• Indications for Use: (listed on page 2)
• Specific Limitation: To be used only with Ti6Al4V alloy hip stems with the CeramTec 5°42'30" (+0',-5') cone angle.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study based on the provided text. The document is a regulatory approval, not a scientific study report.

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