Biologics U.S. Product Portfolio - Zimmer Biomet

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BiologicsU.S. ProductPortfolio

Table of ContentsOur Philosophy.2Osteoconductive Materials.4Calcigen Synthetic Bone Graft. 5Subchondroplasty (SCP ) Procedure. 6β Beta-bsm Bone Substitute Material . 7γGamma-bsm Bone Substitute Material. 8Osteoinductive Materials.9EquivaBone Bone Graft Substitute. 10StaGraft Cancellous DBM Sponge and Strips. 11StaGraft DBM Putty and PLUS. 12Osteopromotive Materials*. 13GPS III Platelet Concentration System. 14Plasmax Plasma Concentration Kit. 15BioCUE System. 16*Mixed with autograft and/or allograft boneOsteogenic Materials. 19BOS Bone Marrow Aspiration Kit. 19Ancillary Products.20Perfuse System. 20Complete Bone Remodeling Triad. 21Bonus Triad Allograft. 22Cartilage.23OCA Kit . 23Soft Tissue Management.24DermaSpan Acellular Dermal Matrix. 24AmnioRepair Allograft . 25Electric Bone Stimulation.26OsteoGen Bone Growth Stimulator. 26Indications for Use .27Catalog Part Numbers . 31

2Our PhilosophyStaGraft DBM Putty & PLUSThe Zimmer Biomet Biologics Product Portfolio represents thepassionate pursuit of the most innovative and clinically relevantEquivaBoneBone Graft Substitutesolutions addressing the needs of surgeons and their patients.Zimmer Biomet Biologics offers a myriad of solutions for both hardand soft tissue applications, including bone grafting products,platelet and plasma concentration systems, a BBMA (blood andStaGraft Canc. DBMSponge/Stripsbone marrow aspirate) concentration system, an autologousactivation system and bone marrow aspiration needles. Alsooffered are: cartilage, soft tissue reinforcement, and woundcovering products.Stagraft BSMThe philosophy defining our hard tissue products is based on thecomplex process involved in tissue repair, wherein the matrix/These products also exhibitOsteoconductive propertiesscaffold (osteoconductive), signaling proteins (osteopromotive*and/or osteoinductive), and tissue forming cells (osteogenic)Osteoinductivework in concert to form new tissue (bone).This “Essentials of Bone Remodeling Triad” (osteoconductive,osteoinductive, osteogenic) is the cornerstone of the ZimmerBiomet Biologics Product Portfolio, which is one of the broadestportfolios in the market today.PlasmaxPlasma Concentration SystemBioCUEBBMAGPS IIIPlatelet Concentration SystemConcentration SystemMixed with autograft and/or allograft bone*Products that produce a PRP output do not currently have FDAclearance to be characterized with a specific mechanism of action.PRP, in and of itself (i.e., without the autograft or allograft), is not FDAcleared as “osteopromotive.”Osteopromotive

3 Biologics U.S. Product PortfolioγGamma-bsmMoldable PuttyBeta-bsmInjectableβBonus TriadAllograftOsteoconductiveComplete Bone Remodeling TriadPerFuse PercutaneousDecompressionSystem**Facilitates mixing bone graft materialwith bone marrow aspirate.Osteogenic

4Osteoconductive MaterialsOsteoconductive materials provide the frameworkor scaffolding within a bony environment for cellsto infiltrate and attach. They also offer porosity forvascular pathways and cell migration. Materialsgenerally referred to as osteoconductive includecertain calcium phosphate/calcium sulfate basedsynthetics and allograft cortical as well as cancellouschips, sponges, and strips. 1, 2Although autograft is considered the gold standardfor orthopedic procedures requiring graft material,it has known limitations with associated donor sitemorbidity and limited availability.2 Synthetic bonegraft substitutes have been developed to overcomethese limitations, and the emergence of biomaterials,such as β Beta-bsm Injectable and γ Gamma-bsmMoldable Putty offer many advantages for both thesurgeon and the patient.Self-setting paste options provide the surgeonflexibility to pack, mold, and inject these materials tothe defect site.

5 Osteoconductive MaterialsCalcigen SA quick-setting calcium sulfate that delivers aresorbable and easy to use bone graft material.Designed to harden intraoperatively, Calcigen Sprovides an osteoconductive environment for bonegrowth. Extrudable for 2–3 minutes and hardensin 4–6 minutes Resorbs in approximately 8–12 weeks, dependingon defect size, based on animal studies.5*Simple mixing of the powder and liquid with a spatulaand a tray Flexibility of shapes can be molded into beads,blocks or wedges Ease of setting with bead mold tray* Animal studies may not be predictive of results in humans.

6 Osteoconductive MaterialsSubchondroplasty (SCP ) ProcedureThe Subchondroplasty Procedure is a minimallyinvasive fluoroscopically-assisted intervention thattargets and fills subchondral bone defects, oftencalled Bone Marrow Lesions (BML) with AccuFill BoneSubstitute Material. AccuFill BSM is an engineeredcalcium phosphate mineral compound, a bone graftsubstitute, that resorbs and is replaced with newbone during the healing process.AccuFill BSM is an optimal material for theSubchondroplasty Procedure: Flows readily into closed trabecular bone6 Sets hard within 10 minutes of implantation at37 C, with properties comparable to healthycancellous bone7 Undergoes cell-mediated remodeling asthe bone heals8

7 Osteoconductive MaterialsβBeta-bsm InjectableBeta-bsm Injectable is engineered using ETEX’sproprietary nanocrystalline* calcium phosphatetechnology that mimics the mineral compositionof human bone to provide a scaffold for new bonegrowth.7 It is mixed in a closed syringe to syringesystem and is delivered in minimally invasiveprocedures via a needle as small as 16 g.β User friendly closed mixing system for minimallyinvasive delivery Becomes solid in a wet environment to allowfor irrigation after setting Osteoconductive scaffold 2 minute working time; sets in 3-5 minutes at 37 C Average compressive strength of 30MPa;3x cancellous bone 3,7 Available in 2.5 and 5 cc to accommodatea variety of applications*The grain size of the hydroxyapatite (HA) crystals that form as partof the amorphous and crystalline mixture of calcium phosphatesets are on the nanometer scale. The size of crystalline structureswere measured by x-ray diffraction to be less than 100 nanometers.

8 Osteoconductive MaterialsγGamma-bsm Moldable PuttyγGamma-bsm Moldable Putty is engineered usingETEX’s proprietary nanocrystalline* calcium phosphatetechnology that mimics the mineral composition ofhuman bone to provide a scaffold for new bone growth.7It addresses the need for hard setting, bone substitutematerials that are implanted in a wet environment. User friendly, moldable putty mixed in an opensystem (blood or saline) Osteoconductive scaffold 15 minute working time Sets in 3-5 minutes at 37 C; sets in wetenvironment to allow for irrigation after setting Average compressive strength of 46 MPa;4x cancellous bone 4 Available in 2.5, 5, and 10cc to accommodatea variety of applications*The grain size of the hydroxyapatite (HA) crystals that form as partof the amorphous and crystalline mixture of calcium phosphatesets are on the nanometer scale. The size of crystalline structureswere measured by x-ray diffraction to be less than 100 nanometers.

9Osteoinductive MaterialsOsteoinductive materials induce bone formation ina bony or non-bony environment via the action ofgrowth factors or signaling proteins, including BoneMorphogenetic Proteins (BMPs). These proteinsstimulate the conversion of progenitor cells into boneforming osteoblasts.2,9 Materials that are generallyreferred to as osteoinductive in nature includedemineralized bone matrix (DBM) and BMP products.Zimmer Biomet Biologics products that fit thiscategory include: StaGraft DBM products (Putty*,PLUS,* Cancellous DBM Sponge and Strips), BonusCC Matrix Bone Graft System, and EquivaBone BoneGraft Substitute. In addition, these products alsoexhibit osteoconductive properties.DBM bone void fillers have been developedto overcome the limitations of autograft, and theemergence of biomaterials such as StaGraft DBM,and EquivaBone Bone Graft Substitute offer manyadvantages for both the surgeon and the patient.Ready-to-use DBM Putty and PLUS (combined withceramic osteoconductive granules) options providethe surgeon flexibility to pack and mold thesematerials into the defect site. Cancellous/corticalchips along with cancellous strips and sponges enablethe surgeon to hydrate the materials with biologicfluids, such as blood, PRP, or bone marrow aspirate.Stagraft Fiber* Each lot of DBM incorporated into StaGraft Putty and Plus is assayed for its osteoinductive potential.The combination of DBM, the carrier, and, in some formulations, ceramic granules has not been evaluated for osteoinductivity.

10 Osteoinductive MaterialsEquivaBone Bone Graft SubstituteEquivaBone Bone Graft Substitute combines theosteoinductivity of demineralized bone matrix withthe osteoconductivity, moldability, structure, andhard-setting characteristics of ETEX’s proprietarynanocrystalline* calcium phosphate technology.ETEX nanocrystalline* calcium phosphate mimicsthe mineral composition of human bone, providing ascaffold for new bone growth.7 Osteoconductive scaffold and osteoinductivestimulus Each lot of DBM certified osteoinductiveprior to release DBM promotes bone formation Open mixing system with multiple delivery options(moldable or injectable putty) 15 minute working time Sets in 10 minutes at 37 C; sets in a wetenvironment to allow for irrigation after setting Available in 2.5, 5 and 10cc to accommodatea variety of applications* The grain size of the hydroxyapatite (HA) crystals that form as partof the amorphous and crystalline mixture of calcium phosphatesets are on the nanometer scale. The size of crystalline structureswere measured by x-ray diffraction to be less than 100 nanometers.

11 Osteoinductive MaterialsStaGraft Cancellous DBM Sponge and StripsThe StaGraft Cancellous DBM sponge and strips aremachined from a single piece of cancellous bone.The cancellous bone is demineralized, exposing theinherent growth factors that are essential for newbone formation.Rehydration can be achieved with isotonic solutionincluding blood, bone marrow aspirate (BMA), orsaline solution.10 The demineralization process andtrabecular structure provide sponge-like handling,which allows the grafts to fit into a variety of bonevoids or spinal cavities.If compressed, these products will expand to fill thecontours of a void, thereby minimizing the spacebetween the graft and the host bone. Osteoinductive: Bone fully demineralized tooptimize inherent growth factors that are essentialfor new bone formation. Sponge-Like Handling: When compressed, thegrafts will naturally expand back to their originalstate, allowing them to fill the contours of a void,thereby minimizing the space between the graftand the host bone. Trabecular Structure: The interconnected porosityof cancellous bone allows for cellular infiltration.

12 Osteoinductive MaterialsStaGraft DBM Putty, PLUS and PasteStaGraft DBM is an osteoinductive* demineralized bonematrix in a natural lecithin carrier, and is available as a 40%DBM Putty, 35% DBM PLUS pre-mixed with resorbablecoralline hydroxyapatite calcium carbonate granules or35% DBM Paste. The natural quality of the carrier andits outstanding containment and handling characteristicsenable the surgeon to mold it to surgical sites, even in thepresence of excessive fluids and under lavage. Excellent handling and performance characteristics –tolerates lavage/irrigation DBM-to-carrier ratio engineered for optimizedosteoinductivity 11 StaGraft PLUS with resorbable granules has excellenthandling properties Easy to use – pre-loaded in a syringe;stored at room temperature 2cc DBM Paste available with straightor curved injectors* Each lot of DBM incorporated into StaGraft DBM is assayed for its osteoinductive potential. The combination of DBM, the carrier, and,in some formulations, ceramic granules has not been evaluated for osteoinductivity.** StaGraft DBM is intended for use in bone voids and gaps in the extremities or pelvis that is not intrinsic to the stability of the structure

13Osteopromotive MaterialsOsteopromotive* materials enhance the natural bonehealing process. 12,13 PRP is mixed with autograft orallograft materials to impart better graft-handlingcharacteristics. 15Zimmer Biomet Biologics products that fit thiscategory include the GPS III Platelet ConcentrationSystem, BioCUE Blood and Bone Marrow Aspirate(BBMA) Concentration System, and Plasmax PlasmaConcentration System.*Products that produce a PRP output do not currently have FDA clearanceto be characterized with a specific mechanism of action. PRP, in and ofitself (i.e., without the autograft or allograft), is not FDA cleared as“osteopromotive.”

14 Osteopromotive MaterialsGPS III Platelet Concentration SystemWhole blood contains several components that canbe concentrated during centrifugation to form abuffy coat layer or leukocyte-rich platelet-rich plasma(L-PRP). By utilizing the GPS III Platelet ConcentrationSystem, the patient’s own platelets can be separatedinto a highly concentrated formula. The PRP canbe mixed with autograft or allograft bone prior toapplication at an orthopedic surgical site.Average L-PRP Output Concentrations 90% recovery of available platelets 15 9.3x platelet increase over baseline 15 5x white blood cell increase over baseline 16 6 ml of autologous PRP output 16 15 minutes centrifuge process 16Platelet-Poor PlasmaBuffy Coat (L-PRP)Red Blood Cells

15 Osteopromotive MaterialsPlasmax Plasma Concentration SystemThe Plasmax Plasma Concentration System iscomprised of two distinct parts, the GPS III Separatorand the Plasmax Concentrator. The GPS III Separatorproduces leukocyte-rich platelet-rich plasma (L-PRP) froma small sample of the patient’s own blood. The PlasmaxConcentrator produces autologous fibrinogen-rich plateletpoor plasma concentrate (PPPc)* utilizing polyacrylamidebeads to remove excess water.PlasmaxConcentrator 3x increase in plasma proteins (on average)including fibrinogen17 Outputs up to 10 cc of rapidly polymerizingautologous plasma concentrate Outputs up to 6 cc of platelet-rich plasma(from GPS III Separator) Total centrifugation time is less than 20 minutes Point-of-care preparation No refrigeration requiredGPS III SeparatorPlatelet-Poor PlasmaBuffy Coat (L-PRP)Red Blood Cells*Autologous output from the Plasmax Plasma Concentration System eliminates concern regarding pooled blood sources.Pooled plasma sources found in donor-based fibrin sealants carry the risk of transmitting infectious diseases and viruses.

16 Osteopromotive MaterialsBioCUE Blood and Bone Marrow Aspirate(B BMA) Concentration SystemDesigned to process a mixture of autologouswhole blood and bone marrow aspirate, theBioCUE BBMA Concentration System representsan evolution in this technique. The system includesall the components to DRAW blood, ASPIRATEbone marrow, easily PROCESS the disposablesystem, and produce an autologous PRP outputto HYDRATE the surgeon’s choice of autograft and/orallograft bone.Average PRP Output Concentrations 77.5% recovery of nucleated cells 18 71% recovery of available platelets 18 7.2x concentration of available platelets 18 7.9x concentration of available nucleated cells 18Technique MattersWhen aspirating bone marrow with the BMAneedle provided with the BioCUE System, keepthese best practices in mind: The 6 holes at the distal tip allow for moreefficient collection of aspirate from differentangles within the bone inside the cortical wall. 19 While maintaining a 1:5 ratio of ACD-A to BMAin the aspirating syringe, add a little extraanticoagulant to flush the BMA needle withACD-A as well.Each needle comes witha trocar point and blunt tipfor surgeon options

17 Biologics U.S. Product PortfolioBioCUEBBMAConcentration SystemOCA KitAutologousGPS PlateletConcentration SystemAmniorepairSoft TissueDermaSpanAcellular Dermal MatrixCalcigen SSynthetic Bone Graft

18 Biologics U.S. Product PortfolioBonus Triad AllograftStagraft BSMViable CellAllograftStaGraft DBM Putty & PLUSEquivaBoneBone Graft SubstituteSynthetic AllograftSyntheticγGamma-bsm Moldable PuttyβSubchondroplasty (SCP)ProcedureBeta-bsm Injectable

19Osteogenic MaterialsOsteogenic materials, such as autograft and/orbone marrow aspirate (BMA) and live allograft tissuecontain viable cells, such as mesenchymal stemcells, osteoprogenitor cells, or osteoblasts, which arecapable of synthesizing new bone. 2,9 BMA is typicallycombined with osteoconductive and osteoinductivematerials for bone grafting purposes.Zimmer Biomet has two systems that help obtainand prepare these osteogenic materials. The bonemarrow aspiration kit procures bone marrow aspiratewhile the PerFuse System facilitates mixing bone graftmaterial with bone marrow aspirate.BOS Bone Marrow Aspiration Kit Aspirate can be obtained from a variety ofanatomical locations including the illiac crest, tibia,and calcaneous Six holes placed at distal tip, allowing for efficientaspiration 19 One stylet with trocar point for penetration of thecortical bone into the bone marrow cavity One stylet with blunt tip for easy movement of theneedle within the bone marrow cavity

20 Ancillary ProductsPerFuse Percutaneous Decompression SystemZimmer Biomet ’s PerFuse PercutaneousDecompression System is designed to accessthe femoral head or humeral head for coredecompression. The PerFuse System facilitatesmixing and pre-mixing of bone graft materialwith I.V. fluids, blood, plasma, bone marrow,or other specified blood components deemednecessary by the clinical use requirements.Multiple approaches have been employed toaugment core decompression (e.g. autologous bonemarrow aspirate, synthetic bone graft substitutes,and allograft products including milled trabecularbone and vascularized fibular grafts).Core Decompression is a surgical technique totreat Avascular Necrosis involving drilling oneor more channels into the dead bone (necroticlesion). Creating a channel into the necrotic lesionis intended to relieve intraosseous pressurewithin the bone and provide a channel to restoreblood flow to the diseased bone. 20 Simple ease of use: PerFuse System Cannula creates 6 mm hole,which offers post-op flexibility for physiciano Disposable components are always sharpo 6 mm in diameter with two options in length:Large (295 mm) and Small (161 mm)o Loaner program lowers facility initialinvestment Disposable tamp allows for multiple intraoperative bone graft options Surgical technique eliminates heat generatedby power equipment and lowers the risk ofthermal necrosis

21Complete Bone Remodeling TriadMany currently available bone grafting materials havesome of the features necessary for successful bonehealing, but few possess all three of the componentsof the bone remodeling triad: osteoconductivity,osteoinductivity and osteogenicity. In an effortto provide a graft material that contains all threecomponents without the need to harvest autograft,advanced fresh-frozen allografts were developedfrom cadaveric tissue to meet this medical need.These allografts retain naturally inherent osteogeniccells as well as osteoconductive and osteoinductiveproperties.

22 Complete Bone Remodeling TriadBonus Triad AllograftBonus Triad Allograft is a cryopreserved humantissue allograft consisting of cancellous bonecombined with demineralized cortical bonematrix in uniform granule particle size. This uniquecombination provides all three componentsof the bone remodeling triad: osteoconductive,osteoinductive, and osteogenic.Bonus Triad Allograft has been developed toovercome the limitations of some bone graftsubstitutes and designed to offer a real alternativeto autograft.Osteogenic Provides live osteogenic cells that are critical tothe bone healing processThorough Processing Processed via stringent donor screening,testing and sterility procedures (asepticprocessing) Test samples of Bonus Triad Allograft wereshown to be immune-protective 22, *Excellent HandlingBonus Triad Allograft contains at least 750,000cells/cc of cancellous tissue with at least70% cell viability.21 These cells include MSCs,osteoprogenitor cells and pre-osteoblasts. Graft composition designed to provide excellenthandling: allows for dense graft packingand placement at surgical siteOsteoconductive Cancellous bone matrix offers aninterconnected trabecular structure.This allows for bone in-growth and graftremodelingOsteoinductive Demineralized component provides additionalinherent growth factors*Laboratory results are not necessarily indicative of clinical performance

23CartilageOCA Kit Natural Tissue GraftThe OCA Kit is used for the repair repair ofosteochondral defects and articular cartliagedamage. Addressing cartilage lesions throughcartilage repair can limit the need for furthersurgical intervention and potentially divert theprogression of these lesions to osteoarthritis.The OCA Kit is a convenient osteochondral allograft(OCA) kit packaged with cancellous chips. Thisconfiguration offers surgeons flexibility in addressingmultiple types of osteochondral and cartilage defects. Cells derived from juvenile donor tissue are100-fold more active than their adult counterpartsat producing cartilagenous tissue in vitro23 Juvenile allograft contains 10x the numberof chondrocytes compared to adult tissue The OCA Kit includes 5cc of 1-4 mm cancellouschips Does not elicit an allogeneic immune response23 The graft is implanted in a single stage procedurewith fibrin fixation No need to harvest tissue or cells from areasof undamaged cartilage, thereby saving timein the OR

24Soft TissueDermaSpan Acellular Dermal MatrixDermaSpan Acellular Dermal Matrix is carefullyprocessed to be used for the repair or replacementof damaged or inadequate integumental tissue or forother homologous uses of human integument.DermaSpan Meshed ACD is to be used as acovering for skin wounds (e.g. burns, ulcers) andshould not be used in load-bearing applications. Thestandard allograft (non-meshed) may also be usedfor supplemental support, protection, reinforcementor covering of tendon or ligament, but is not intendedto bear the load.Through a unique, proprietary process DermaSpanAcellular Dermal Matrix is supplied sterile (SAL-10-6).Histology studies have shown Precision DoseSterilization allows the graft to be sterilized whilemaintaining integrity. 24 Acellular dermal matrix derived from allografthuman skin Infiltrated by host tissue in animal studies 24, ** Animal studies are not necessarilyreflective of clinical results.Examples of Non-Load BearingPotential Applications:Achilles TendonReinforcementWoundCoverage

25 Tissue ManagementAmnioRepair Amniotic Membrane AllograftStructural proteins act as a scaffold for cellularattachment and migration. Placental tissue has severalstructural matrix components that aid in cell migrationand attachment including Collagen type IV, Fibronectin,Laminin, and Glycosaminoglycans (GAGs).AmnioRepair Allograft is a lyophilized placentalmembrane allograft that is aseptically processedto preserve the native extracellular matrix andendogenous proteins. Amniorepair Allograft isintended for homologous use as a barrier, forminga protective cover for a variety of acute and chronicwounds. Clinical cases include wound cover of the foot andankle.25 AmnioRepair Allograft uses a proprietaryfreeze-drying solution during lyophilization,which preserves key growth factors.26*In- vitro and animal studies are not necessarily indicative of clinical performance.

26 Electronic Bone StimulationOsteoGen Bone StimulationThe OsteoGen Surgically Implantable BoneGrowth Stimulator is a useful adjunct for treatingnonunions where surgery is already planned orwhere patient noncompliance may be a factor withpulsed electromagnetic fields (PEMF). Because theOsteoGen is totally implanted, your patient is assuredof the therapeutic treatment at the nonunion site.OsteoGen is compatible with the surgical treatmentcommonly used for management of transverse,segmented, and comminuted nonunions of thefemur, tibia, fibula, humerus, clavicle, ulna and radius.The OsteoGen Stimulator may be used as an adjunctto internal/external fixation and autograft. EBI OsteoGen Implantable Stimulator is clinicallyproven. In one 10 year follow-up clinical study, theOsteoGen Implantable Stimulator achieved an 85%success rate in healing tibia nonunions.27 Direct current stimulation has been shown invarious in vitro and animal studies to upregulategene expression for multiple growth factorsincluding Bone Morphogenic Proteins (BMP)-2,-6, and -728**Pre-Clinical studies involve scientific testing of a drug/device to evaluate its feasibility prior to being studied in humans. This testing is often performedutilizing in vitro cell cultures and/or animal models. The results of pre-clinical studies may not be indicative of human clinical outcomes.

27Indications for UsePlease see package inserts for additional device information/labeling.ProductClinical IndicationsGPS III Platelet Concentrate Separation Kitwith ACD-AThe GPS III Platelet Concentrate Separation Kit with ACD-A is designed to be used for thesafe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample ofthe patient’s blood at the point of care. The PRP can be mixed with autograft and allograftbone prior to application to an orthopedic surgical site as deemed necessary by the clinicaluse requirements.Plasmax Plasma ConcentratorThe Plasmax Plasma Concentrator Accessory aids in the concentration of the patient’s ownplasma proteins by centrifugation utilizing a Biomet Biologics centrifuge. Excess water isremoved from the platelet-poor plasma (PPP) with desalting beads. GPS III Mini PlateletConcentrate Separation Kit with ACD-A. The GPS III Mini Platelet Concentrate SeparationKit with ACD-A aids separation of the patient’s own blood components by density throughthe use of a Biomet Biologics centrifuge.BioCUE Platelet Concentration SystemThe BioCUE Platelet Concentration System consists of a standard (containing 60 mlseparator) or a mini (containing 30 ml separator) kit. The kit separates a mixture of thepatient’s blood and bone marrow components by density through the use of the BioCUESeparator and a Biomet Biologics centrifuge. The system contains syringes, blood drawcomponents, a separator, and bone marrow aspiration (BMA) needle. The BioCUESeparator permits platelet poor plasma (PPP) and platelet rich plasma (PRP) to be rapidlyprepared from a small volume of a mixture of the patient’s blood and bone marrow that isdrawn at the time of treatment.AccuFill SCPAccuFill Bone Substitute Material is an injectable, self-setting, macroporous,osteoconductive, calcium phosphate bone graft substitute material that is intended for usto fill bony voids or gaps of the skeletal system of the extremities, spine (ie, posterolateralspine), and the pelvis that are not intrinsic to the stability of the bony structure. Thesedefects may be surgically created osseous defects or osseous defects created fromtraumatic injury to the bone. AccuFill BSM is a bone graft substitute that resorbs and isreplaced with new bone during the healing process.Beta-bsm Injectable bone Substitute Material is an implantable bone graft that is asynthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for usein filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateralspine and pelvis) that are not intrinsic to the stability of the bony structure. These defectsmay be surgically created osseous defects or osseous defects created from traumaticinjury to the bone.

human bone to provide a scaffold for new bone growth. 7 It addresses the need for hard setting, bone substitute materials that are implanted in a wet environment. User friendly, moldable putty mixed in an open system (blood or saline) Osteoconductive scaffold 15 minute working time Sets in 3-5 minutes at 37 C; sets in wet