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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
Animal studies
chronOS® β-tricalcium phosphate Granules, blocks, and wedges Osteoconduction Animal studies 510(k) cleared
Bioresorbable
Calceon® 6 Calcium sulfate Pellets Osteoconduction Animal studies 510(k) cleared
Bioresorbable
OSTEOSET® Surgical grade calcium sulfate Various sized pellets Osteoconduction Human studies 510(k) cleared
Bioresorbable Case reports
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
Animal studies
CELLPLEX® Tricalcium phosphate Various sized granules Osteoconduction Case reports 510(k) cleared
Bioresorbable Animal studies
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
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
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
CopiOs® Cancellous Bone Graft Bovine bone Cancellous chips, cancellous cubes and wedges Osteoconduction Case reports 510(k) cleared
Animal studies
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
  1. Data were extracted based on the reports of FDA, American Academy of Orthopedic Surgeons, and information provided by the manufacturers.