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 8 Commercially available bone graft substitutes: part 4

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
Synthes	Norian^® SRS^® Fast Set Putty	Calcium phosphate	Moldable putty	Osteoconduction	Human studies	510(k) cleared
				Bioresorbable	Case reports
				Bioresorbable	Animal studies
	chronOS^®	β-tricalcium phosphate	Granules, blocks, and wedges	Osteoconduction	Animal studies	510(k) cleared
	chronOS^®	β-tricalcium phosphate	Granules, blocks, and wedges	Bioresorbable	Animal studies	510(k) cleared
	Calceon^® 6	Calcium sulfate	Pellets	Osteoconduction	Animal studies	510(k) cleared
	Calceon^® 6	Calcium sulfate	Pellets	Bioresorbable	Animal studies	510(k) cleared
	OSTEOSET^®	Surgical grade calcium sulfate	Various sized pellets	Osteoconduction	Human studies	510(k) cleared
				Bioresorbable	Case reports
				Bioresorbable	Animal studies
Wright Medical Technology	MIIG^® X3	High strength surgical grade calcium sulfate	Minimally invasive injectable graft for compression fractures	Osteoconduction	Human studies	510(k) cleared
				Bioresorbable	Case reports
				Bioresorbable	Animal studies
	CELLPLEX^®	Tricalcium phosphate	Various sized granules	Osteoconduction	Case reports	510(k) cleared
	CELLPLEX^®	Tricalcium phosphate	Various sized granules	Bioresorbable	Animal studies	510(k) cleared
	ALLOMATRIX^®	DBM with/without CBM in surgical grade calcium sulfate powder	Various volumes of injectable/ formable putty	Osteoconduction	Human studies	510(k) cleared
				Bioresorbable	Case reports
				Osteoinduction	Animal studies
				Osteoinduction	Cell culture
	ALLOMATRIX^® RCS	DBM with CACIPLEXTM Technology in surgical grade calcium sulfate powder	Various volumes of formable putty	Osteoconduction	Animal studies	510(k) cleared
				Bioresorbable
				Osteoinduction
	IGNITE^®	DBM in surgical grade calcium sulfate powder to be mixed with bone marrow aspirate	Percutaneous graft for problem fractures	Osteoconduction	Human studies	510(k) cleared
				Bioresorbable	Case reports
				Osteoinduction	Animal studies
				Osteoinduction	Cell culture
Zimmer	CopiOs^® Bone Void Filler	Dibasic calcium phosphate and Type I collagen	Sponge and paste	Osteoconduction	Case reports	510(k) cleared
				Bioresorbable	Animal studies
				Osteogenesis and osteoinduction when mixed with bone marrow aspirate	Animal studies
	CopiOs^® Cancellous Bone Graft	Bovine bone	Cancellous chips, cancellous cubes and wedges	Osteoconduction	Case reports	510(k) cleared
	CopiOs^® Cancellous Bone Graft	Bovine bone	Cancellous chips, cancellous cubes and wedges	Osteoconduction	Animal studies	510(k) cleared
	Puros^® Demineralized Bone Matrix	DBM putty	Putty	Osteoconduction	Every lot tested in vivo for osteoinduction	100% derived from allograft tissue
				Bioresorbable		FDA clearance not required
				Osteoinduction		FDA clearance not required

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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