(83 days)
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.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.