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Learn About Allografts

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Image of a DNA Helix representing Recombinant
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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.

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  • Recombinant proteins or combination products that contain recombinant proteins are osteoinductive
  • Depending on what other components are included, they may be osteoconductive

COMPARISON OF GRAFT PROPERTIES

 OsteoconductiveOsteoinductiveOsteogenic
 Mineralized Allograftstick icon  
Demineralized Allograftstick icontick icon 
Cellular Allograftstick icontick icontick icon
Autograft*tick icontick icontick icon
Syntheticstick icon  

Recombinant Proteins

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Combination Grafts

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Xenografttick icon  

*Autograft is partially demineralized, and therefore its osteoinductivity (signals) are unenhanced compared to grafts with fully demineralized bone.

  • As Class III medical devices, recombinant proteins or combination products have specific indications listed in its Instructions for Use (IFU).
  • All other use is considered off-label in contrast to allograft and autograft which can be used anywhere bone formation is needed.
  • LifeNet Health offers natural bone allografts

References

References
  1. https://www.medtronic.com/us-en/healthcare-professionals/products/spinal-orthopaedic/bone-grafting/infuse-bone-graft.html Accessed 516.2022
  2. https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100006d.pdf
  3. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-products-drugs-and-devices-and-additional-product-classification-issues. Accessed 5/13/2022