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 |