đź“‹ 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
510K
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.
Clinical Applications
Commonly used in orthopedic and oncological procedures, the BII-Graft 6140 is particularly useful in tumor ablation surgeries where bone reconstruction is necessary. It is also employed in dental surgeries and maxillofacial reconstructions. The device is suitable for use in both hospital and outpatient surgical settings.
Indications for Use
The FDA-cleared indications for the BII-Graft 6140 include its use in bone grafting procedures, particularly in cases where bone defects need to be filled following tumor removal. It is suitable for patients requiring bone regeneration.
Practical Considerations
The BII-Graft 6140 comes in various particle sizes to accommodate different surgical needs. It is compatible with standard surgical techniques and tools. Surgeons should ensure proper handling to maintain the integrity of the graft material during implantation.
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.