Table 6 Commercially available bone graft substitutes: part 2
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 |
|---|---|---|---|---|---|---|
Integra Orthobiologics/(IsoTis OrthoBiologics) | Accell 100â„¢ | DBM putty | Injectable putty | Osteoconduction | Human studies | 510(k) cleared |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
Every DBM lot tested for osteoinduction | ||||||
Accell Connexus® | DBM plus reverse phase medium | Injectable putty | Osteoconduction | Human studies | 510(k) cleared | |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
Every DBM lot tested for osteoinduction | ||||||
Accell TBMâ„¢ | Total bone matrix, 100% preformed | Various-sized strips | Osteoconduction | Human studies | 510(k) cleared | |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
Every DBM lot tested for osteoinduction | ||||||
Integra Mozaikâ„¢ | 80% highly purified B-TCP | Strip and putty | Osteoconduction | Animal studies | 510(k) cleared | |
20% highly purified type-1 collagen | Bioresorbable | Case reports | ||||
LifeNet Health | Optium DBM® | DBM combined with glycerol carrier | Formable putty (bone fibers) and injectable gel (bone particles) | Osteoconduction | Human studies | 510(k) cleared |
Bioresorbable | Case reports | |||||
Osteoinduction | Animal studies | |||||
IC Graft Chamber® | DBM particles and cancellous chips | Lyophilized and packaged in various sizes within a delivery chamber | Osteoconduction | Animal studies | Regulated under CFR 1270 and 1271 as a human tissue and 510(k) cleared | |
Bioresorbable | Case reports | |||||
Osteoinduction | ||||||
Designed to be used with blood, PRP, or bone marrow to enhance DBM activity | ||||||
Cellect DBM® | DBM fibers and cancellous chips | Provided in a specialized cartridge | Osteoconduction | Animal studies | Regulated under CFR 1270 and 1271 as a human tissue and 510(k) cleared | |
Bioresorbable | Case reports | |||||
Osteoinduction | ||||||
Designed for the retention of osteoprogenitor cells | ||||||
Medtronic Spinal & Biologics | INFUSE® Bone Graft | rhBMP-2 protein on an absorbable collagen sponge | Multiple kit sizes | Bioresorbable carrier | Human studies (level I and level III data) | PMA approved for fusion with spinal cage |
Osteoinduction | Case reports | PMA approved for open tibia fractures with IM nail | ||||
Chemotaxis of stem cells; indirect osteogenesis | Animal studies | |||||
MasterGraft® Granules | Biphasic calcium phosphate | Granules | Osteoconduction | Animal studies | 510(k) cleared | |
Bioresorbable | ||||||
MasterGraft® Matrix | Calcium phosphate and collagen | Compression resistant block | Osteoconduction | Animal studies | 510(k) cleared | |
Bioresorbable | ||||||
MasterGraft® Putty | Calcium phosphate and collagen | Moldable putty | Osteoconduction | Animal studies | 510(k) cleared | |
Bioresorbable |