Learn About Allografts
Recombinants and Combination
Bone grafting products with recombinant proteins provide a large dose of a signaling protein that is associated with bone formation. BMP-2 comes with a bovine collagen sponge which acts as a carrier for the growth factor.1 PDGF-BB is provided with beta tri-calcium phosphate that acts as a scaffold.2 Both of these products are considered combination products. There are several definitions of combination products, in for these, the relevant section "A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity".3
An example of a combination product that does not include a recombinant protein is a short peptide sequence bound to anorganic bovine bone.