Bone graft selection is critical to the outcome of any bone healing procedure. There are currently over 200 different bone grafts available to surgeons today, each with substantial differences in technology, materials, mechanisms of action, indications, and clinical evidence.
Bone grafts can be categorized based on:
Recombinant proteins are naturally occurring proteins that play an active role in bone formation and maintenance. The human sequence of these proteins can be synthetically manufactured in a consistent, controlled process — commonly referred to as "human recombinant" technology, or recombinant human bone morphogenetic protein (rhBMP).
An osteoconductor, synthetic autograft extender bulks up the supply of available autograft bone.
There are many different allograft products or forms available for use. Some allograft tissue functions through osteoconduction and mild osteoinduction when demineralized, and include mineralized tissue, demineralized tissue, and allograft tissue plus cells.
These products are also regulated differently based on how they are processed. For example, tissue based products that have a 351 HCT/Ps designation are regulated like a medical device and require a submission to the FDA for clearance. Tissue based products that fall into the minimally manipulated category are regulated as a 361 HCT/P and do not require a submission to the FDA.
Xenograft is bone taken from an animal source and transplanted into the body. It is treated at high temperatures (600 C to 100 C) to eliminate contamination.
1. What is bone graft technology’s composition?
2. What is the technology’s MOA?
3. How was the technology approved/cleared and for what indication?
4. What type of performance data are required for FDA approval/clearance?