Table 7 Commercially available bone graft substitutes: part 3
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 |
|---|---|---|---|---|---|---|
Medtronic Spinal & Biologics | Progenixâ„¢ DBM Putty | DBM in type1 bovine collagen and sodium alginate | Ready to use injectable putty | Osteoconduction | Animal studies | 510(k) cleared |
Bioresorbable | ||||||
Osteoinduction | ||||||
Osteofil® DBM | DBM in porcine gelatin | Injectable paste and moldable strips | Osteoconduction | Animal studies | 510(k) cleared | |
Bioresorbable | Case reports | |||||
Osteoinduction | ||||||
MTF/Synthes | DBX® | DBM in sodium hyaluronate carrier | Paste, putty mix, and strip | Osteoconduction | Human studies | 510(k) cleared |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
NovaBone/ MTF | NovaBone® | Bioactive silicate | Particulate and putty | Osteoconduction | Case reports | 510(k) cleared |
Bioresorbable | Animal studies | |||||
Osteostimulation | ||||||
Orthovita | Vitoss® | 100% β-TCP and 80% β-TCP/20% collagen | Putty, strip, flow, morsels, and shapes | Osteoconduction | Published human studies | 510(k) cleared |
Bioresorbable | Case reports | |||||
Animal studies | ||||||
Osteotech | Grafton® | DBM combined with glycerol | Formable putty, injectable gel, putty mixed with chips, flexible sheets, and matrix | Osteoconduction | Published human studies | 510(k) cleared |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
Graft on Plus® | DBM combined with a starch carrier | Paste | Osteoconduction | Case reports | 510(k) cleared | |
Bioresorbable | Animal studies | |||||
Osteoinduction | ||||||
Regeneration Technologies | BioSetâ„¢ | DBM combined with natural gelatin carrier | Injectable paste, injectable putty, strips, and blocks with cortical cancellous chips | Osteoconduction | Human studies | 510(k) cleared |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
Every lot tested in vivo for osteoinduction | ||||||
Smith & Nephew | VIAGRAF | DBM combined with glycerol | Putty, paste, gel, crunch, and flex | Osteoconduction | Animal studies | 510(k) cleared |
Bioresorbable | ||||||
Osteoinduction | ||||||
Stryker Biotech | OP-1® Implant | rhBMP-7 with type 1 bone collagen | Lyophilized powder reconstituted to form wet sand | Bioresorbable scaffold | Human studies (level I data) | HDE approval for long bone non-unions |
Osteoinduction | Case reports | |||||
Animal studies | ||||||
OP-1® Putty | rhBMP-7 with type 1 bone collagen | Lyophilized powder reconstituted to form putty | Bioresorbable scaffold | Human studies (level I data) | HDE approval for revision posterolateral fusion | |
Osteoinduction | Case reports | |||||
Animal studies | ||||||
Calstruxâ„¢ | Tricalcium phosphate with carboxymethylcellulose | Moldable putty | Osteoconduction | Animal studies | 510(k) cleared | |
Bioresorbable |