Summary of typical bone-graft substitutes that are commercially available

Transcription

1 Summary of typical bone-graft substitutes that are commercially available Company AlloSource AlloFuse TM Heat sensitive copolymer with DBM Injectable gel and putty Cell culture Biomet Osteobiologics DePuy Exactech BonePlast BonePlast Quick Set InterGro ProOsteon 500R CONDUIT TCP Granules HEALOS Bone Graft Replacement Optecure Optecure + CCC Optefil Opteform OpteMx TM Calcium sulfate with or without HA/CC composite granules Calcium sulfate DBM in a lecithin carrier Coralline-derived HA/CC composite Various volumes of powder and setting solution Quick setting paste Paste, putty and mix with HA/CC composite granules Granular or block 100% β-tcp Granules Mineralized collagen matrix DBM suspended in a hydrogel carrier DBM and CCC suspended in a hydrogel carrier DBM suspended in gelatin carrier DBM and cortical cancellous suspended in gelatin carrier HA/TCP biphasic combination Variety of strip sizes Dry mix kit delivered with buffered saline Dry mix kit delivered with buffered saline Injectable bone pastedry powder ready to be hydrated Formable putty or dry powder ready to be hydrated Granules, sticks, rounded wedges, wedges and cylinders in several sizes Osteoconductive Creeping substitution Compressive strength of 400psi Osteogenesis and limited when Every lot tested for, studies : marrow Page

2 Integra Orthobiologics/ (IsoTis OrthoBiologics) Life Net Health Medtronic Spinal & Biologics Accell Connexus Accell Evo3 TM Accell TBM DynaGraft II OrthoBlast II Integra Mozaik TM IC Graft Chamber Optium DBM INFUSE Bone Graft MasterGraft Granules MasterGraft Matrix DBM, Accell Bone Matrix, Reverse Phase Injectable putty DBM, Accell Bone Matrix, Reverse Phase Injectable putty DBM, Accell Bone Matrix DBM, Reverse Phase DBM, cancellous bone, Reverse Phase 80% highly purified b-tcp/ 20% highly purified Type-1 collagen DBM particles and cancellous DBM combined with glycerol carrier rhbmp-2 protein on an absorbable collagen sponge phosphate (15% HA / 85% b-tcp) phosphate and collagen Various sized strips Injectable putty Injectable putty Strip and putty Lyophilized and packaged in various sizes within a delivery chamber Formable putty (bone fibers) and injectable gel (bone particles) Multiple kit sizes Granules Compression resistant block Designed to be used with blood, PRP or bone marrow to enhance DBM activity carrier Chemotaxis of stem cells; indirect osteogenesis Every DBM lot tested for Every DBM lot tested for Every DBM lot tested for Every DBM lot tested Every DBM lot tested (Level I and Level III data) Regulated under CFR 1270 and 1271 as a human tissue and PMA approved for fusion with spinal cage PMA approved for open tibia fractures with IM nail : marrow Page

3 Medtronic Spinal & Biologics MasterGraft Putty MasterGraft Strip Osteofil DBM Progenix TM Plus Progenix Putty phosphate and collagen phosphate (15% HA and 85% b-tcp) and collagen DBM in porcine gelatin DBM in Type-1 bovine collagen and sodium alginate DBM in Type-1 bovine collagen and sodium alginate Moldable putty Compression resistant strip Injectable paste and moldable strips Putty with demineralized cortical bone Ready to use injectable putty : autograft : marrow and/or autograft and/or sterile water : marrow : autograft bone MTF/ Orthofix Trinity Evolution TM Viable Cellular Bone Matrix Multiple volumes available Osteogenesis 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 NovaBone/ MTF NovaBone Bioactive silicate Particulate, putty and morsels Osteostimulation Published human studies Orthovita Vitoss 100% b-tcp and 80% b-tcp/ 20% collagen and 70% b-tcp/20% collagen/10% bioactive glass Putty, strip, flow, morsels and shapes Bioactive/ osteostimulation Osteogenesis and when Published human studies (Level I and III) Page 3

4 Osteotech A-Flex Crunch Flex Gel Matrix PLF Matrix Scoliosis Strips Orthoblend Large Defect Orthoblend Small Defect DBM fiber technology Round flexible sheet DBM fibers with demineralized cortical cubes DBM fiber technology DBM in a syringe DBM fiber technology Packable graft Various sizes of flexible sheets MIS and Percutaneous injectable graft Single and double troughs DBM fiber technology Various sizes of strips DBM fibers with crushed cancellous DBM fibers with larger cancellous Packable graft Packable moldable graft Case Reports Animal Studies Page 4

5 Osteotech GRAFTON Plus Paste Putty DBM in a syringe DBM fiber technology Injectable MIS graft, resists irrigation Packable moldable graft Regeneration Technologies BioSet TM DBM combined with natural gelatin carrier Injectable paste, injectable putty, strips and blocks with cortical cancellous Smith & Nephew VIAGRAF DBM combined with glycerol Putty, paste, gel, crunch and flex Stryker Biotech Synthes OP-1 Implant OP-1 Putty rhbmp-7 with Type-1 bone collagen rhbmp-7 with Type-1 bone collagen plus carboxymethylcellulose (putty additive) Calceon 6 Calcium sulfate Pellets chronos b-tcp Lyophilized powder reconstituted with saline to form wet sand-like consistency Lyophilized powder reconstituted with saline to form wet sand-like consistency Granules, blocks and wedges Norian SRS Calcium phosphate Injectable paste Norian SRS Fast Set Putty Calcium phosphate Moldable putty scaffold scaffold (Level I data) (Level I data) HDE approval for long bone nonunions HDE approval for revision posterolateral lumbar fusion Page 5

6 Wright Medical Technology Zimmer ALLOMATRIX ALLOMATRIX RCS ALLOPURE CANCELLO-PURE Wedges DBM with/without CBM in surgical powder Various volumes of injectable/ formable putty DBM with CACIPLEX TM Various volumes of technology in surgical formable putty powder Sterile femoral/tibial allograft Bovine bone 12mm Evans wedge 6mm Cotton wedge 10mm x 50mm wedge 12mm Evans wedge 6mm Cotton wedge CELLPLEX b-tcp Various sized granules IGNITE MIIG X3 OSTEOSET PRO-DENSE Injectable Regenerative Graft PRO-STIM Injectable Inductive Graft CopiOs Bone Void Filler CopiOs Cancellous Bone Graft Puros DBM DBM in surgical powder to be mixed with bone marrow aspirate High strength surgical Surgical grade calcium sulfate 75% calcium sulfate and 25% calcium phosphate 50% calcium sulfate, 10% calcium phosphate, and 40% DBM by weight Dibasic calcium phosphate and Type- 1 collagen Bovine bone Allograft DBM putty (putty with includes allograft from the same donor) Percutaneous graft for problem fractures Minimally invasive injectable graft for compression fractures Various sized pellets Procedure kits, various volumes of injectable paste Procedure kits, various volumes of injectable paste/ formable putty Dense bone regeneration Accelerated healing vs. autograft Sponge and paste Osteogenesis and when Cancellous, cancellous cubes and cortico-cancellous wedges Putty and putty with Cell culture Mechanical Testing Cell culture 100% derived from allograft tissue Regulated under 21 CFR Parts 1270 and 1271 as a human tissue Resorbable calcium salt bone void filler device : autologous blood products like blood or bone marrow Every lot tested in an 100% derived from in vivo rat assay for allograft tissue osteoinductive potential Regulated under 21 demonstrating bone CFR Parts 1270 and formation in an ectopic 1271 as a human model tissue Page 6 AAOS 2010