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

Oryan, Ahmad; Alidadi, Soodeh; Moshiri, Ali; Maffulli, Nicola

doi:10.1186/1749-799X-9-18

Journal of Orthopaedic Surgery and Research

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
				Biodegradable	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
	BonePlast^®	Calcium sulfate with or without HA/CC composite granules	Various volumes of powder and setting solution	Biodegradable	Animal studies	510(k) cleared
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	Animal studies
	CONDUIT^® TCP Granules	100% β-TCP	Granules	Osteoconduction	Case reports	510(k) cleared
	CONDUIT^® TCP Granules	100% β-TCP	Granules	Biodegradable	Animal studies	510(k) cleared
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	Animal studies

Data were extracted based on the reports of FDA, American Academy of Orthopedic Surgeons, and information provided by the manufacturers.

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ISSN: 1749-799X

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