(179 days)
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.
Not Found
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.
§ 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.