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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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The Headloc™ Ceramic Femoral Head for the Primaloc™ Cemented Hip System is intended for single-use cemented implantation during primaryrevision 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™ Cemeted Hip System which is cleared for use under Premarket Notification K962448.

Headloc™ Zirconia Ceramic Heads

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance results, study details (sample sizes, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment relevant to an AI/ML device.

The document is a 1997 FDA 510(k) clearance letter for a medical device called "Headloc™ Zirconia Ceramic Heads" and outlines its intended use and regulatory classification. It does not describe any studies comparing its performance against specific acceptance criteria in the context of AI/ML or diagnostic accuracy.

Ask a specific question about this device