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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 100™ 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 TBM™ 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 Mozaik™ 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
  1. Data were extracted based on the reports of FDA, American Academy of Orthopedic Surgeons, and information provided by the manufacturers.