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BIO DBMTM
Solutions from Stryker
• Verifiedosteoinductivepotentialpoststerilization1,2
• Graftsterilitypreservedthroughvalidatedsterilizationprocesses1,2
• Multipleformsandsizestoaddressawiderangeofprocedures
References1. Data on file Allosource2. 2Data on file at RTI Surgical, Inc.3. Walsh WR, Oliver R, Yu Y, et al., Demineralized Bone Matrix Provides Equivalent Results to Autograft in Standard Posterolateral Fusion Model in Adult Rabbits. AlloSource White Paper, 2012 4. Lewis, C.S..Hillard, R., Griffith, M., “Evaluation of Stryker BIO DBM and Grafton Matrix PLF,” p. 2
A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: BIO DBM, BIO DBM Boat, BIO DBM Putty, BIO DBM Shape. All other trademarks are trademarks of their respective owners or holders. Copyright © 2015 Stryker, Printed in USABIDBM-BR-2
Ordering Information
Product Length Width CC QTY/PackReference NumberBIODBMBoat(Single) 5 cm 2.5cm 10cc 1 65305001BIODBMBoat(Short) 5 cm 2.5cm 20cc 2 653050BIODBMBoat(Long) 10 cm 2.5cm 40cc 2 653100
Product Diameter Height CC QTY/PackReference NumberBIODBMShape 16mm 5mm 1cc1 65401BIODBMShape 25.2mm 5mm 2.5cc 1 65402BIODBMShape 35.7mm 5mm 5cc 1 65405
Description Size Delivery Reference Number
1cc Syringe 7776001
BIODBMGel 5cc Syringe 7776005
10cc Syringe 7776010
1cc Vial 7775001
BIODBMPutty 2.5cc Vial 7775025
5cc Vial 7775005
10cc Vial 7775010
BIODBMPlusPutty 5cc Vial 7777005
(withCancellous) 10cc Vial 7777010
Reconstructive
Hips
Knees
Trauma&Extremities
Foot&Ankle
JointPreservation
Orthobiologics&Biosurgery
MedSurg
PowerTools&SurgicalAccessories
ComputerAssistedSurgery
EndoscopicSurgicalSolutions
IntegratedCommunications
Beds,Stretchers&EMS
Reprocessing&Remanufacturing
Neurotechnology & Spine
Craniomaxillofacial
InterventionalSpine
Neurosurgical,Spine&ENT
Neurovascular
SpinalImplants
Available through: Stryker Spine2 Pearl CourtAllendale, New Jersey 07401
Phone: +1 201 760 8000Fax: +1 201 760 8108www.stryker.com
Spine
BIO DBM Putty,PuttyPlus,andGel• Demonstratedequivalentboneformationresultstoautograft
instandardposteriorlateralfusionmodelinadultrabbits3
• ReversedPhaseMediumCarrierisdesignedtoprovideexcellenthanding
• Formulatedtoresistirrigation• Everylotistestedtoconfirmosteoinductivepotential• PuttyPlusconfigurationscontaincancellousbone1
Control Autograft DBMwithreversephasemedium
Boats• Deeptrough-likedesignengineeredtodeliverlocalbone/
allograftchips• Designedforrapidhydrationandhighvolumeretentionof
bloodorsaline• Longandshortsizesasoptionsforsingleandmulti-level
placementaspartofposterolateralfusionprocedures• 10,20and40ccsizes
Shapes• Easilymoldedintosmallanatomyapplications• Designedforrapidhydrationandhighvolumeretention
ofbloodorsaline• Pliableconsistencyallowsforeasyirrigationof
bone/allograftchips• 1,2.5and5ccsizes
Gel• Syringeinjectable• Easilymoldable• 1,5and10ccsizes
HighOsteoinductivePotential
BIO DBM BoatandShapes
Figure 1. Average percentage of new bone formation for each implant group over 12 weeks. Nine implants across three lots/donors were averaged.
Figure 2. Average bone maturity score for each implant group over 12 weeks. Nine samples across three lots/donors were averaged.
BIO DBMBoatvs.LeadingCompetitionBoththeStrykerBIODBMBoatandOsteotechGraftonMatrixPLFshowhistologicalevidenceofnewboneformationinathymicratectopicpouchmodel.TheboneformationscoresachievedateachtimepointforBIODBMBoatwerecomparabletothoseattainedforGraftonMatrixPLF.2
TheBIODBMBoatgraft,however,reachedhigherlevelsofboneformationatafasterratethantheGraftonMatrixPLgraft.4
BIODBMBoat GraftonMatrixPLF
%N
ewB
one
Form
atio
n
80.00
70.00
60.00
50.00
40.00
30.00
20.00
10.00
0.00 1 2 4 8 12
BIODBMBoat GraftonMatrixPLF
Bon
eM
atur
ity
10.00
8.00
6.00
4.00
2.00
0.00
1 2 4 8 12
BIO DBM
Variabilityinallografttissueisalwaysaconcernasnotwodonorsarealike,whichiswhyeachlotofBIODBMPutty,GelandPlusaretestedusingahighlyregardedinvivotesttoconfirmosteoinductivepotential.
DBMcombinedwithareversephasemediumdemonstratedequivalentboneformationresultstoautograftinstandardposteriorlateralfusionmodelinadultrabbits.3
ThreedimensionalreconstructedCTimagesshowevidenceofboneformationinboththeautograftandDBMspecimen.Noboneformationappearsinthecontrolspecimen.Studyshowednostatisticaldifferencewhencomparedtoautograft.
• Naturalbiologicscaffoldtosupportboneingrowth• Sterilizedwithvalidatedtissuesterilizationprocessesthatinclude
viralinactivationsteps2
• Hightoleranceformanipulationandirrigation
Putty and Putty Plus• Vialpackaged• Resistsirrigation• 1,2.5,5and10ccsizes• PuttyPluscontainscancellousbone