Table 1.
Commercial demineralized bone matrix preparations.
| Company | Commercially available product | Composition | Commercially available forms | Claimed mechanisms of action | Burden of proof | FDA status |
|---|---|---|---|---|---|---|
| AlloSource | AlloFuseTM | Heat sensitive copolymer with DBM | Injectable gel and putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Case reports • Animal studies • Cell culture |
510(k) cleared • Bone graft extender • Bone void filler |
| Biomet Osteobiologics | InterGro® | DBM in a lecithin carrier | Paste, putty and mix with HA/CC composite granules | • Osteoconduction • Bioresorbable • Osteoinduction |
• Case reports • Animal studies • Every lot tested for osteoinduction |
510(k) cleared • Bone graft extender • Bone void filler |
| Exactech | Optecure® | DBM suspended in a hydrogel carrier | Dry mix kit delivered with buffered saline | • Osteoconduction • Bioresorbable • Osteoinduction • Osteogenesis when mixed with autogenous bone graft |
• Human studies • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft extender • Bone void filler |
| Optecure® + CCC | DBM and CCC suspended in a hydrogel carrier | Dry mix kit delivered with buffered saline | • Osteoconduction • Bioresorbable • Osteoinduction • Osteogenesis when mixed with autogenous bone graft |
• Human studies • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft extender • Bone void filler |
|
| Optefil® | DBM suspended in gelatin carrier | Injectable bone paste-dry powder ready to be hydrated | • Osteoconduction • Bioresorbable • Osteoinduction • Osteogenesis when mixed with autogenous bone graft |
• Human studies • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone void filler |
|
| Opteform® | DBM and cortical cancellous chips suspended in gelatin carrier | Formable putty or dry powder ready to be hydrated | • Osteoconduction • Bioresorbable • Osteoinduction • Osteogenesis when mixed with autogenous bone graft |
• Human studies • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone void filler |
|
| Integra Orthobiologics/(IsoTis OrthoBiologic) | Accell Connexus® | DBM, Accell Bone Matrix, Reverse Phase Medium | Injectable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Every DBM lot tested for osteoinduction |
510(k) cleared extremities, pelvis • Bone void filler extremities, pelvis, spine • Bone graft extender |
| Integra Orthobiologics/(IsoTis OrthoBiologic | Accell Evo3TM | DBM, Accell Bone Matrix, Reverse Phase Medium | Injectable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Animal studies • Every DBM lot tested for osteoinduction |
510(k) cleared extremities, pelvis • Bone void filler extremities, pelvis, spine • Bone graft extender |
| Accell TBM® | DBM, Accell Bone Matrix | Various sized strips | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Every DBM lot tested for osteoinduction |
510(k) cleared extremities, pelvis • Bone void filler extremities, pelvis, spine • Bone graft extender |
|
| DynaGraft II | DBM, Reverse Phase Medium | Injectable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Every DBM lot tested for osteoinduction |
510(k) cleared | |
| OrthoBlast II | DBM, cancellous bone, Reverse Phase Medium | Injectable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Every DBM lot tested for osteoinduction |
510(k) cleared extremities, pelvis • Bone void filler extremities, pelvis, spine • Bone graft extender |
|
| LifeNet Health | IC Graft Chamber® | DBM particles and cancellous chips | Lyophilized and packaged in various sizes within a delivery chamber | • Osteoconduction • Bioresorbable • Osteoinduction • Designed to be used with blood, PRP or bone marrow to enhance DBM activity |
• Animal studies • Case reports |
• Regulated under CFR 1270 and 1271 as a human tissue |
| Optium DBM® | DBM combined with glycerol carrier | Formable putty (bone fibers) and injectable gel (bone particles) | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies |
510(k) cleared • Bone void filler |
|
| Medtronic Spinal & Biologics | Osteofil® DBM | DBM in porcine gelatin | Injectable paste and moldable strips | • Osteoconduction • Bioresorbable • Osteoinduction |
• Animal studies • Case reports |
510(k) cleared • Bone void filler |
| ProgenixTM Plus | DBM in Type-1 bovine collagen and sodium alginate | Putty with demineralized cortical bone chips | • Osteoconduction • Bioresorbable • Osteoinduction |
• Animal studies • Case reports |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| Progenix™ Putty | DBM in Type-1 bovine collagen and sodium alginate | Ready to use injectable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Animal studies • Case reports |
510(k) cleared extremities, pelvis • Bone graft substitute • Bone void filler spine • Bone graft extender: must be used with autograft bone |
|
| MTF/Orthofix | Trinity EvolutionTM | Viable cellular bone matrix | Multiple volumes available | • Osteogenesis • Osteoinduction • Osteoconduction |
• Animal studies • Case reports |
• Regulated under CFR 1270 and 1271 as a human tissue |
| MTF/Synthes | DBX® | DBM in sodium hyaluronate carrier | Paste, putty mix and strip | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies |
510(k) cleared • Bone graft extender • Bone void filler |
| Osteotech | GRAFTON® A-Flex® | DBM fiber technology | Round flexible sheet | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
| GRAFTON® Crunch® | DBM fibers with demineralized cortical cubes | Packable graft | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| GRAFTON® Flex® | DBM fiber technology | Various sizes of flexible sheets | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| GRAFTON® Gel | DBM in a syringe | MIS and Percutaneous injectable graft | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender |
|
| GRAFTON® Matrix PLF | DBM fiber technology | Single and double troughs | • Osteoinduction Osteoconduction Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender |
|
| Osteotech | GRAFTON® Matrix Scoliosis Strips | DBM fiber technology | Various sizes of strips | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
| GRAFTON® Orthoblend Large Defect | DBM fibers with crushed cancellous chips | Packable graft | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| GRAFTON® Orthoblend Small Defect | DBM fibers with larger cancellous chips | Packable moldable graft | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| GRAFTON Plus® Paste | DBM in a syringe | Injectable MIS graft, resists irrigation | • Osteoinduction • Osteoconduction • Incorporation/ complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| GRAFTON® Putty | DBM fiber technology | Packable moldable graft | • Osteoinduction • Osteoconduction • Incorporation/complete remodeling • Osteogenesis when mixed with bone marrow aspirate or autogenous bone graft |
• Peer-reviewed published human studies (incl. Levels I–II prospective studies) • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone graft substitute • Bone graft extender • Bone void filler |
|
| RegenerationTechnologies | BioSetTM | DBM combined with natural gelatin carrier | Injectable paste, injectable putty, strips and blocks with cortical cancellous chips | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Every lot tested in vivo for osteoinduction |
510(k) cleared • Bone void filler |
| Smith &Nephew | VIAGRAF | DBM combined with glycerol | Putty, paste, gel, crunch and flex | • Osteoconduction • Bioresorbable • Osteoinduction |
• Animal studies | 510(k) cleared • Bone void filler |
| Wright Medical Technology | ALLOMATRIX® | DBM with/without CBM in surgical grade calcium sulfate powder | Various volumes of injectable/formable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Cell culture |
510(k) cleared • Bone void filler |
| ALLOMATRIX® RCS | DBM with CACIPLEXTM technology in surgical grade calcium sulfate powder | Various volumes of formable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Animal studies | 510(k) cleared • Bone void filler |
|
| IGNITE® | DBM in surgical grade calcium sulfate powder to be mixed with bone marrow aspirate | Percutaneous graft for problem fractures | • Osteoconduction • Bioresorbable • Osteoinduction |
• Human studies • Case reports • Animal studies • Cell culture |
510(k) cleared • Bone void filler |
|
| PRO-STIM™ Injectable Inductive Graft | 50% calcium sulfate, 10% calcium phosphate, and 40% DBM by weight | Procedure kits, various volumes of injectable paste/formable putty | • Osteoconduction • Bioresorbable • Osteoinduction |
• Case reports • Animal studies |
510(k) cleared • Resorbable calcium salt bone void filler device |
|
| Zimmer | Puros® DBM | Allograft DBM putty (putty with chips includes allograft chips from the same donor) | Putty and putty with chips | • Osteoconduction • Bioresorbable • Osteoinduction |
• Every lot tested in an in vivo rat assay for osteoinductive potential demonstrating bone formation in an ectopic model | • 100% derived from allograft tissue • Regulated under 21 CFR Parts 1270 and 1271 as a human tissue |