📋 FDA Reference
Bio-Interfaces Inc Bioresorbable Calcium Phosphate Particles - Bii-Graft 6140
Bio-Interfaces
Summary: The BII-Graft 6140 is a bioresorbable calcium phosphate particle device used primarily in tumor ablation procedures. It is typically utilized by surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K960164 ↗
Decision Date ?
April 10, 1996
Product Code ?
LYC
Device Class ?
Class 2
Evidence ?
0 studies
The BII-Graft 6140 received FDA clearance through the 510k pathway on April 10, 1996. Manufactured by Bio-Interfaces, it is classified as a Class 2 medical device.
What It Is
The BII-Graft 6140 is a medical device composed of bioresorbable calcium phosphate particles. These particles are designed to be used in surgical procedures where bone grafting is required. The material is gradually resorbed and replaced by the patient's own bone over time, facilitating natural healing and integration.
FDA-Cleared Indications
- Use as a bone-graft material to fill bone defects where bone regeneration is needed.
- Use in surgical management of bone defects associated with tumor removal, when reconstruction or defect filling is indicated.
Clinical Applications
- Filling selected bone defects after surgical removal of a bone tumor.
- Supporting bone reconstruction during orthopedic surgery.
- Filling bone defects during maxillofacial or dental surgery when the product labeling permits the procedure.
- Use as a resorbable calcium phosphate particle graft material in hospital or outpatient surgery.
Practical Considerations
- Particle size should be selected according to the defect, surgical approach and product labeling.
- The material must be handled and implanted according to the manufacturer's instructions so the particles are not contaminated or damaged.
- It is a bone-graft substitute, not a fixation device; plates, screws or other stabilization may be needed when mechanical support is required.
- MRI safety depends on the complete implanted construct and any accompanying hardware. The current device labeling should be checked before MRI.
- Contraindications, precautions, defect size limits and infection-related restrictions should be confirmed in the original instructions for use; the FDA record summary alone does not provide these details.
Frequently Asked Questions
What is BII-Graft 6140 used for?
BII-Graft 6140 is used for bone grafting in tumor ablation and other reconstructive surgeries.
What specialties typically use this device?
Orthopedic surgeons, oncologists, and maxillofacial surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in bone grafting procedures, particularly in filling bone defects post-tumor removal.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.