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Table 5 Commercially available bone graft substitutes: part 1

From: Bone regenerative medicine: classic options, novel strategies, and future directions

Company Commercially available product Composition Commercially available forms Claimed mechanisms of action Level of evidence FDA status
AlloSource AlloFuse™ Heat-sensitive copolymer with DBM Injectable gel and putty Osteoconduction Case reports 510(k) cleared
Biodegradable Animal studies
Osteoinduction Cell culture
Biomet Osteobiologics ProOsteon® 500R Coralline-derived hydroxyapatite/calcium carbonate (HA/CC) composite Granular or block Osteoconduction Human studies 510(k) cleared
Biodegradable Case reports
Animal studies
InterGro® DBM in a lecithin carrier Paste, putty, and mix with HA/CC composite granules Osteoconduction Case reports 510(k) cleared
Biodegradable Animal studies
Osteoinduction Every lot tested for osteoinduction
BonePlast® Calcium sulfate with or without HA/CC composite granules Various volumes of powder and setting solution Osteoconduction Case reports 510(k) cleared
Biodegradable Animal studies
DePuy Spine HEALOS® Bone Graft Replacement Mineralized collagen matrix Variety of strip sizes Osteoconduction Peer-reviewed, published human studies 510(k) cleared
Creeping substitution Case reports
Osteoinduction Animal studies
Osteogenesis when mixed with bone marrow aspirate
CONDUIT® TCP Granules 100% β-TCP Granules Osteoconduction Case reports 510(k) cleared
Biodegradable Animal studies
Exactech Opteform® DBM and cortical cancellous chips suspended in gelatin carrier Formable putty or dry powder ready to be hydrated with autologous diluents or saline Osteoconduction Human studies 510(k) cleared
Biodegradable Case reports
Osteoinduction Animal studies
Osteogenesis when mixed with autogenous bone graft Every lot tested in vivo for osteoinduction
Optefil® DBM suspended in gelatin carrier Injectable bone paste; dry powder ready to be hydrated with blood or saline Osteoconduction Human studies 510(k) cleared
Biodegradable Case reports
Osteoinduction Animal studies
Osteogenesis when mixed with autogenous bone graft Every lot tested in vivo for osteoinduction
Optecure® DBM suspended in a hydrogel carrier Dry mix kit delivered with or buffered saline mix with patient's autogenous bone graft or autologous diluents Osteoconduction Human studies 510(k) cleared
Biodegradable Case reports
Osteoinduction Animal studies
Osteogenesis when mixed with autogenous bone graft Every lot tested in vivo for osteoinduction
Optecure® + CCC DBM and CCC suspended in a hydrogel carrier Dry mix kit delivered with buffered saline or mix with patient's autogenous bone graft or autologous diluents Osteoconduction Animal studies 510(k) cleared
Biodegradable Every lot tested in vivo for osteoinduction
Osteoinduction
Osteogenesis when mixed with autogenous bone graft
OpteMx™ HA/TCP biphasic combination Granules, sticks, rounded wedges, wedges, and cylinders in several sizes Osteoconduction Human studies 510(k) cleared
Biodegradable Case reports
Compressive strength of 400 psi Animal studies
Osteogenesis and limited osteoinduction when mixed with bone marrow aspirate
  1. Data were extracted based on the reports of FDA, American Academy of Orthopedic Surgeons, and information provided by the manufacturers.