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Surgical Technique
Polaris™ System Translation™ Screw
Game Changing Technology• 3mmofmedial-lateraltranslation
encouragesoptimalscrewplacement• Lessrodmanipulation,easier
rodintroduction
Unparalleled Thread Performance• Balanced-start™Tip• Maximizesscrewinteraction
invariousbonedensities
Less Stress at Bone-to-Screw Interface
3mmofTranslation
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Section1 Introduction...............................................Page1 FeaturesandBenefits................................Page2 Implants....................................................Page3 Instruments...............................................Page5
Section2 SurgicalApproachandPreparation...........Page11 PediclePreparation...................................Page11 ScrewSelectionandInsertion...................Page12
Section3 RodApplication.........................................Page14 RodReduction...........................................Page15 RodRocker............................................Page15 ShortRocket™ThreadedReducer..........Page16 LongRocket™ThreadedReducer...........Page18 PerpendicularRodPersuader................Page21
Section4 HelicalFlange®PlugApplication................Page22 FinalLocking.............................................Page22
Section5 SpondylolisthesisReduction.....................Page24
Section6 AdditionalSurgicalOptions.......................Page27 DistractionandCompression.................Page27 CrossConnectorApplication.................Page28 LateralConnectors.................................Page28 ScrewHeightAdjustment......................Page29 ImplantRemoval....................................Page29
Section7 Closure,PostOperativeCare.....................Page31
Section8 IndicationsforUse....................................Page31 Contraindications......................................Page31 Warnings...................................................Page32 LimitsofSystemCompatibility..................Page32 Precautions...............................................Page33 SterilizationInformation............................Page33 U.S.SterilizationParameters.....................Page33 SterilizationParameters forUseOutsidetheU.S.:...........................Page33
Section9 OrderingInformation.................................Page34 FurtherInformation...................................Page37
Contents
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Section 1: Introduction
BiometproudlyintroducesthePolaris™Translation™Screw.
Translation™Screwtechnologyrepresentsprogressive
innovationaimedatprovidingsolutionsfortoday’s
thoracolumbarfusionchallenges.
ThePolaris™Translation™Screwprovides3mmof
medial-lateraltranslationand40°ofconicalangulation
allowingpediclescrewstobeplacedanatomically.
Thisflexibilitywillpermitthescrewseatstoadjustto
thenaturaltrajectoryoftherodandminimizestressatthe
bone-to-screwinterfacethatcanbeseenwithtraditional
pediclescrewconstructs.
TheextensiveclinicalexperiencegainedfromthePolaris™
SpinalSystemisreflectedineverydesignaspectofthe
screw.TheBalanced-start™Tipimmediatelyengages
thepedicleandaccuratelyleadsthescrewintothepilot
hole.Thedualleadthreadprofilereducesinsertiontime
whilemaximizingbonepurchaseandstrength.Reliable
HelicalFlange®Technologyminimizescrossthreading
andseatsplay,whileenhancingthestrengthofthelocking
mechanism.Thescrewseatfeaturesarobustengagement
betweentheimplantandtheversatileportfolioofreduction
instruments,suchastheRocket™Reducer.
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Features and Benefi ts
Feature Benefi t
Translation™Screw
Technology
3mmofmedial-lateral
translationrelativetothe
screwshaft
Encouragesoptimal
screwplacement
Lessrodmanipulation,
easierrodintroduction
Balanced-start™Tip
Minimizestoggle
duringinsertion
Accurateplacement
andscrewtrajectory
Immediatebone
engagement
DoubleLeadThreadFastandefficient
screwplacement
ThreadProfile
Tactileinsertion
Threadformmaximizes
bonepurchase
andperformance
Constantouterdiameter
FrictionFitSeatMaintainsposition
ofscrewseat
HelicalFlange®Technology
Startseasily
Minimizescrossthreading
andseatsplay
Forcesare
concentratedinward
Multi-axialScrews40°ofconicalangulation
foroptimumversatility
5.5mmrodsystemLowprofile
Anatomicalfit
Color-codedimplants Easeofscrewidentification
Source:BSP231119L.
Dual-Lead
Screw Thread
• Fasterscrew placement
HelicalFlange®
Technology
Balanced-start™
Tip Geometry
• Minimizestoggle duringinsertion
• Accurateplacement andscrewtrajectory
• Immediatebone engagement
Thread Profi le
• Maximizesthescrewinteractioninvarious bonedensities
• Tactileinsertion
• Threadformmaximizesbonepurchase
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Implants
ThePolaris™Translation™ScrewSystemiscompatiblewith
theimplantofferingofthePolaris™5.5SpinalSystem.
Figure3:HelicalFlange®Plug
Figure4:LateralConnector-25mmsizeshown
Figure1:Polaris™Translation™Screwsareavailablein
4.75,5.5,6.5,and7.5mmdiametersin30-55mmlengths
Figure2:Polaris™Translation™IliacScrewsareavailablein
6.5,7.5and8.5mmdiametersin35-100mmlengths
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Implants (Continued)
Figure7:Pre-Cut,ContouredRodsareavailable
in5mmincrements
Figure8:TelescopingandAngulatingCrossConnectors*
Figure5:Multi-axialScrewsareavailablein4.75,5.5,6.5,7.5
and8.5mmdiametersin30-55mmlengths.
Figure6:Multi-axialReductionScrewsareavailablein4.75,
5.5,6.5,7.5and8.5mmdiametersin30-55mmlengths.
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Instruments
Figure12:BonePlaner
Figure13:HeadPositioner
Figure14:ScrewShaftRemover
Figure9:DoubleLeadTapsareavailablein4.0,4.75,5.5,6.5
and7.5mmdiameters
Figure10:DoubleLeadIliacTapsareavailablein6.5,7.5,
8.5,9.5and10.5mmdiameters
Figure11:ButtonLockScrewInserter
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Instruments (Continued)
Figure18:RatchetHandle-T
Figure19:FixedTeardropHandle
Figure20:RatchetTeardropHandle
Figure21:AwlShaft
ThePolaris™Translation™ScrewSystemiscompatiblewith
theinstrumentofferingofthePolaris™5.5SpinalSystem.
Figure15:FixedHandle-T
Figure16:FixedHandle-Straight
Figure17:RatchetHandle-Straight
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Figure26:StiffPedicleSound
Figure27:FlexiblePedicleSound
Figure28:TrialPins
Figure29:Multi-axialScrewInserter
Figure22:ThoracicPedicleProbe
Figure23:StraightPedicleProbe
Figure24:CurvedPedicleProbe
Figure25:SingleLeadTap
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Instruments (Continued)
Figure34:TeardropPlugInserter
Figure35:DoubleEndPlugStarter
Figure36:RodRocker
Figure37:ShortRocket™ThreadedReducer
Figure30:DorsalHeightAdjuster
Figure31:RodTemplate
Figure32:RodHolder
Figure33:RodBender
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Figure42:PerpendicularRodPersuader
Figure43:SoftTissueRetractor
Figure44:Compressor
Figure45:Distractor
Figure38:LongRocket™ThreadedReducer
Figure39:OffsetT-Handle
Figure40:OffsetT-Handle
Figure41:QCAdaptor
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Instruments (Continued)
Figure50:TorqueStabilizer
Figure51:ReductionScrewBreak-OffStabilizer
Figure52:ReductionScrewBreak-OffPliers
Figure46:CrossConnectorTorqueWrench
Figure47:TorqueLimitingWrench.AssembledfromPlug
DriverandTorqueLimitingHandle.
Figure48:PlugDriver
Figure49:TorqueLimitingHandle
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Section 2: Surgical Approach and Preparation
Figure54:Confirmingpediclecontainmentwith
PedicleSound
Trialpinsmaybeutilizedtoconfirmtheproperorientation
andtrajectory.
Figure55:UsetheTrialPinstoensureproperorientation
andtrajectory
AlthoughtheScrewsareself-tapping,Tapsareavailablewith
theSystemandmaybeutilizedtopreparethepediclehole.
SelectthecorrespondingTapforthechosenscrewdiameter
andadvancetheTapintothepedicleholeusingtheQuick
ConnectHandle.TheTapsarelasermarkedandhavevisual
bandstohelpindicatethedepthtowhichtheTaphas
beeninserted.
NOTE:TheTapsareline-to-linewiththediameterofthe
Polaris™Translation™Screws.
Thepatientispositionedpronewithhipsinextension
toprovideformaximallumbarlordosis.Thespineis
subperiostallyexposedthroughamidlineorparamedian
incisionandadecompressionisperformed,ifindicated.
Decorticationmustbemeticulouslyperformed.Graftcanbe
placedorpackedintotheposterolateralgutterseitherbefore
orafterthepediclescrewshavebeenimplanted.
Pedicle Preparation
Afteradequateexposureisachieved,theappropriatepedicle
entrypointisselectedandtheentrancetothepedicleis
createdwithanawl,burr,orcurette.
APedicleProbemaybeutilizedtocreatethepedicleholeby
advancingtheProbetoadepthofapproximately30-40mm
usingthedepthmarkingsasaguide.TheProbesarelaser
markedandhave10mmvisualbandstohelpindicatethe
depthtowhichtheProbehasbeeninserted.
Figure53:PedicleProbeisutilized
ThePedicleSoundisthenusedtoconfirmbonycontainment
ofthepedicleholebypalpatingallfourwallsaswellas
thebottomoftheholethroughthepedicleandintothe
vertebralbody.
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Figure57:InsertthetipoftheInserterintothepentalobeof
theScrew
Rotatetheknurledbarrelinaclockwisedirectiontothread
theoutershaftintotheseat.Completelyloadtheoutershaft
intotheseat.SecureitinplacebypushingtheSliderdistally,
asindicatedbythearrow.ConfirmthattheScrewisstraight
andsecureintheInserter.
Figure58:Rotatetheknurledbarrelandthreadtheoutershaft
intotheseat.PushSliderdistallytosecure.
Figure56:PreparethepedicleholewiththeTap
Screw Selection and Insertion
Multi-axialscrewsareavailableinseveraldiametersand
lengths.TheappropriateScrewlengthisdeterminedbyusing
thedepthmarkingsonthePedicleProbeorPedicleSound.
TheMulti-axialScrewsmaybeloadedfreehandorwhile
seatedwithinthesurgicaltray.AttachtheButtonLock
ScrewInsertertotheQuickConnectHandlebypullingback
ontheplungeratthebaseofthequickconnectmechanism,
insertingtheshaft,andreleasingtheplungertolockthe
shaftinplace.
HoldtheScrewbytheScrewshaftandloadtheScrewonto
thetipoftheScrewInserter.Ensurethatthemalepentalobe
atthedistaltipoftheScrewInserterisfullyseatedwithinthe
femalepentalobelocatedatthetopoftheScrewshaft.
Section 2: Surgical Approach and Preparation (Continued)
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Optional Step:Ifatactile,audibleandvisualconfirmationis
desired,whiletheoutershaftisthreadedintotheseat,push
theSliderdistally,asindicatedbythearrow.Thenfollowthe
InserterandScrewassemblyinstructionsasdescribedabove.
TheScrewisadvancedintothepedicletothedesireddepth.
Duringinsertion,guidetheInserterbyholdingtheblack
sleeveontheshaftoftheinstrument.
Figure59:Insertthescrewintothepedicle
TheScrewInserterisdisengagedfromtheScrewby
depressingthe“Unlock”buttonontheknurledbarreland
rotatingtheknurledbarrelinacounterclockwisedirection
andthenliftingtheInserterfromtheScrew.
Figure60:Todisengagedepressthe“Unlock”buttonand
rotatethebarrelcounterclockwise
OncetheScrewsareproperlypositioned,theScrewseatcan
betranslatedandorientedusingtheHeadPositioner.AQuick
ConnectHandlemaybeattachedattheproximalendofthe
HeadPositioner.
Figure61:ScrewheadadjustmentwithHeadPositioner
TheBonePlanerallowsthesurgeontoquicklyremove
asmallamountofbonethatmaybeinterferingwiththe
translationofthescrewseatorapplicationofaRodreduction
instrument.AQuickConnectHandlemaybeattachedatthe
proximalendoftheBonePlaner.
Figure62:BonePlanerremovingbone
Figure63:BonePlaner
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Figure65:InsertRodusingtheRodHolder
Figure66:UtilizetheRodBendertoaddadditionalcurvature
toRod
OnceallScrewshavebeeninserted,choosetheappropriate
lengthRodaccordingtotheconstruct.TheRodTemplate
maybeusedtoaidinRodselection.TheRodshould
projectatleast2mmbeyondtheScrewseatsattheend
oftheconstruct.Besuretoaccountforlargecurvesand
distractionswhenchoosingRodlength.
Figure64:MeasurelengthoftheRodusingtheRodTemplate
TheuniquedesignofthePolaris™Translation™Screws
willadapttoanyrequiredmedialorlateraloffset,thereby
minimizingtheneedforcoronalplaneRodbendinthe
scolioticspine.TheRodshouldbecontouredtocorrectthe
spinetothedesiredthoracickyphosisandlumbarlordosisin
thesagittalplane.ThePolaris™SpinalSystemoffersanarray
ofTitaniumandCobaltChromeAlloyRodswithastrength
rangetomatchthedemandsoftheclinicalcontext.
Section 3: Rod Application
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Rod Rocker
AttachtheRodRockertoScrewseat,andcantileverortiltthe
RockerdowntopersuadetheRodintotheScrewseat.Once
theRodisproperlyseated,HelicalFlange®Plugapplication
canbeexecuted.TheRodRockerfacilitates10mmofsimple
Rodreduction.
Figure67:RodRocker
Rod Reduction
ItmaybenecessarytoreducetheRodintotheScrewseat.
UtilizetheRodRocker,aRocket™ThreadedReducerorthe
PerpendicularRodPersuadertoproperlypositiontheRod
withintheScrewseat.
UtilizetheBonePlanertoquicklyremoveasmallamountof
boneortissuethatmaybeimpedingthepositioningofaRod
reductioninstrument.RefertoSection2forBonePlaneruse.
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Short Rocket™ Threaded Reducer
AttachtheShortRocket™ThreadedReducerbydepressing
thespringloadedarmsandpositioningitintothemating
screwseatgeometry.Theinternalstopensures
properpositioning.
Figure68:AttachmentofShortRocket™ThreadedReducer
NOTE:ToproperlyattachandremovetheShortRocket™
ThreadedReducer,ensurethattheReduceris
completelyunthreaded.
RotatetheproximalbarrelclockwisetosecuretheReducer
andsimultaneouslyreducetheRod.AstheRodisbeing
reduced,theReducer’suniquefeaturesguidetheRodinto
properScrewheadposition.
Figure69:Self-centeringreductiondesign
Figure70:RodReduction
Section 3: Rod Application (Continued)
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Figure72:PartialRemovaloftheShortRocket™Reducer
Figure73:ProperremovaloftheShortRocket™
ThreadedReducer
UtilizetheT-HandleorQuickConnectAdaptortorotatethe
proximalbarreluntiltheRodisfullyreducedandthepositive
stopisreached.OncetheRodisproperlyseated,Helical
Flange®Plugapplicationcanbeexecuted.TheShortRocket™
Reducerfacilitates30mmoftactileRodreduction.
TodisengagetheShortRocket™ThreadedReducer,rotate
theproximalbarrelcounterclockwise.OncetheReduceris
completelyunthreaded,depressthespringloadedarmsand
removetheReducer.
Figure71:PlugInsertionthroughtheShortRocket™Reducer
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Long Rocket™ Threaded Reducer
Tofacilitateattachment,ensurethatthelasermarkedline
iswithinthetwolasermarkedlinesandalignedtothe
“ATTACH”textontheshaftoftheReducerandaredproximal
bandisvisible.AttachtheLongRocket™ThreadedReducer
bypositioningthespringloadedarmsintothematingScrew
seatgeometry.Theinternalstopensuresproperpositioning.
Section 3: Rod Application (Continued)
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Figure76:Rodreduction
Figure74:AttachmentofLongRocket™ThreadedReducer
RotatetheproximalbarrelclockwisetosecuretheReducer
andsimultaneouslyreducetheRod.AstheRodisbeing
reduced,theReducer’suniquefeaturesguidetheRodinto
properScrewheadposition.
Figure75:Self-centeringreductiondesign
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TodisengagetheLongRocket™ThreadedReducer,rotate
theproximalbarrelcounterclockwise.Thespringloadedtips
willautomaticallydisengagefromtheimplantwhenthered
proximalbandiscompletelyvisible.
Figure79:EasyremovaloftheLongRocket™Reducer
UtilizetheT-HandleoptionsorQuickConnectAdaptorto
rotatetheproximalbarreluntiltheRodisfullyreducedand
thepositivestopisreached.OncetheRodisproperlyseated,
HelicalFlange®Plugapplicationcanbeexecuted.TheLong
Rocket™Reducerfacilitates30mmoftactileRodreduction.
Figure77:PlugInsertionthroughtheLongRocket™Reducer
Figure78:PartialRemoval
Section 3: Rod Application (Continued)
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Perpendicular Rod Persuader
WhenusingthePerpendicularRodPersuader,placethe
PersuaderoverthetopoftheScrewseat.Theinternalstop
ofthePersuaderwillensuretheinstrumentisinthecorrect
positionontheseattofacilitatemanipulation.Squeezethe
coloredhandleoftheRodPersuadertofullyseattheRodin
theScrewseat.
Figure80:ProperpositioningofRodPersuader
ThePlugInserterwillfitthroughthecannulatedbodyofthe
Persuader,allowingforPlugapplicationwiththePersuader
inplace.ThePerpendicularRodPersuaderfacilitates45mm
ofcontrolledRodreduction.
Figure81:PlugInsertionthroughRodPersuader
ToreleasethePersuader,pressthemetallictriggerlocated
underneaththecoloredhandle.Oncereleased,thePersuader
maythenberemovedfromtheimplant.
Refertothechartbelowforproperinstrumentoperation
Attachment
Complete
Rod
Reduction
Disengagement
Position of
the visual red
band at the
proximal end
Position of
laser marked
line and text
on shaft of
the Reducer
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Section 4: Helical Flange® Plug Application
Whenallthepediclescrewshavebeeninsertedandthe
RodshavebeenplacedintheScrewseats,theconstruct
isthensecuredusingHelicalFlange®Plugs.Firmlypress
aPlugontotheself-retainingproximalendoftheTeardrop
PlugInserter.AllPlugsshouldbeplacedandthen
provisionallytightened.
Figure82:LoadaPlugontotheTeardropPlugInserter
TheTorqueStabilizermaybeusedtorepositiontheaxisof
theScrewseatwhilesimultaneouslyactingasaguideforthe
PlugDriver.
Final Locking
Afterprovisionaltightening,properimplantplacementshould
beconfirmedwithradiographs.ThePlugsarethentightened
withtheTorqueLimitingWrenchincombinationwiththe
TorqueStabilizer.TheTorqueLimitingHandleattachesto
thePlugDriver.InserttheTorqueLimitingWrenchthrough
theTorqueStabilizer.PositionthetipoftheTorqueWrench
intothePlug.SeatthedistalendoftheTorqueStabilizerover
theScrewseatandconfirmthattheStabilizerfitsfirmlyon
theRod.TheRodwillbepositionedwithintheslotsof
theStabilizer.
Figure83:ProperpositioningoftheTorqueLimitingWrench
intothePentalobeofPlug
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TheTorqueLimitingWrenchisturnedinaclockwise
directionwhiletheTorqueStabilizerisfirmlyheldwith
resistiveforceinacounterclockwisedirection.TheTorque
LimitingWrenchshouldbeturneduntilanaudibleclickis
heardandatactileindicationfelt,confirmingproperfinal
tighteningbyapplying110in-lbs.oftorque.
.
Figure84:FinalTightening
NOTE:UsetheTorqueLimitingWrenchincombinationwith
theTorqueStabilizerforproperfinaltighteningoftheHelical
Flange®Plugs.
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FollowthestepsasdescribedinSection2forpedicle
preparation,pediclescrewinsertionandRodplacement.
PlaceandprovisionallytightenHelicalFlange®Plugs
intheScrewseatsofthecranialandcaudalvertebrae.
Figure85:L5/S1Spondylolisthesis
Inordertoaidinthereductionofthespondylolisthesis,it
isrecommendedtofirstperformaTransforamenalLumbar
InterbodyFusionoftheaffectedlevel.Theadditionofa
TLIFwilldistracttheinterbodyspaceallowingforpartial
reductionofthelisthesis.PleaserefertotheZyston®Surgical
TechniqueGuideforproperutilizationofthesystems.
NOTE:Careshouldbetakeninpatientssuspected
ofhavingosteopeniaorosteoporosiswhenusing
reductioninstruments.
UtilizetheLongThreadedRocket™Reducertoreducethe
spondylolisthesisinacontrolledandtactilemanner.To
facilitateattachment,ensurethatthelasermarkedline
iswithinthetwolasermarkedlinesandalignedtothe
“ATTACH”textontheshaftoftheReducerandaredproximal
bandisvisible.AttachtheReducerbypositioningthespring
loadedarmsintothematingscrewseatgeometry.The
internalstopensuresproperpositioning.
Section 5: Spondylolisthesis Reduction
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Figure86:AttachmentofLongRocket™Reducer
RotatetheproximalbarrelclockwisetosecuretheReducer
andsimultaneouslyreducetheRod.AstheRodisbeing
reduced,theReducer’suniquefeaturesguidetheRodinto
properScrewheadposition.
Figure87:Self-centeringreductiondesign
Figure88:Rodreduction
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UtilizetheT-HandleoptionsorQuickConnectAdaptorto
rotatetheproximalbarreluntiltheRodisfullyreducedand
thepositivestopisreached.OncetheRodisproperlyseated,
Plugapplicationcanbeexecuted.TheLongRocket™Reducer
facilitates30mmoftactileRodreduction.
Figure89:PlugInsertionthroughtheLongRocket™Reducer
TodisengagetheLongRocket™ThreadedReducer,rotate
theproximalbarrelcounterclockwise.Thespringloadedtips
willautomaticallydisengagefromtheimplantandthered
proximalbandwillbecompletelyvisible.
Figure90:FullReductionoftheL5/S1Spondylolisthesis
Section 5: Spondylolisthesis Reduction (Continued)
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Distraction and Compression
Distractionandcompressioncanbeachievedbyutilizing
eithertheDistractororCompressor.Bothinstrumentspermit
intraoperativeapplicationoflineardistractionorcompression
atanylevel.ThedistaltipsoftheDistractororCompressor
areplacedontheRodandthedesireddegreeofdistraction
orcompressionisapplied.Thedistractionorcompression
devicewillmaintainthepositionofthevertebrauntilthe
PlugisprovisionallytightenedwiththePlugInserter.
Figure91:Compression
Figure92:Distraction
Section 6: Additional Surgical Options
Ifneeded,theRodGrippercanbeutilizedasapointof
fixationintheabsenceofanimplant.
Figure93:DistractingoffRodGripper
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Cross Connector Application
Intheeventthatadditionaltorsionalstabilityisrequired,
aCrossConnectormaybeutilized.TheCrossConnector
shouldbeappliedaftertheconstructhasbeenassembledand
thePlugshavebeentightened.
Figure94:SelectappropriatesizedCrossConnector
ApplytheCrossConnectortotheRodsandtightenthe
screwswiththeCrossConnectorTorqueWrenchuntilan
audibleclickisheardandatactileindicationfelt,confirming
propertighteningbyapplying40in-lbsoftorquetotheset
screws.Tightentheoutersetscrewsfirstfollowedbythe
centralsetscrew.
Figure95:Torquethesetscrewsonthecrossconnector.
Torqueuntilanaudibleclickisheardtoapply40in-lbs.
Lateral Connectors
LateralConnectorsmaybeutilizedifscrewplacement
requiresaseverebendintheRod.TheLateralConnectors
allowforanoffset,thusminimizingRodbending.TheLateral
ConnectorsaresecuredwiththesameHelicalFlange®Plug
asthepediclescrews.
Figure96:SelectappropriatesizeLateralConnector
PlacethearmoftheLateralConnectorinthepedicle
screwseatandsecuretheLateralConnectorinplaceby
provisionallytighteningthePlug.Placethelongitudinalrod
intotheseatoftheLateralConnector.Oncetherodhasbeen
placed,inserttheHelicalFlange®Plugintotheseatofthe
LateralConnectorandtightenasdescribedinSection4.
Figure97:LateralConnectorplacement
Section 6: Additional Surgical Options (Continued)
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Screw Height Adjustment
TheDorsalHeightAdjustermaybeusedtoadjusttheScrew
heightpriortoRodplacement.Seatthemalepentalobeof
theDorsalHeightAdjusterintothefemalepentalobelocated
atthetopoftheScrewshaft.TurntheAdjusterforminor
manipulationoftheScrewheight.
Figure98:DorsalHeightAdjustment
Implant Removal
RemovalofthePolaris™SpinalSystemisperformedby
reversingtheorderoftheimplantprocedure.Identifythe
anatomicallocationsoftheimplants.
TheQuickConnectFixedT-HandleattachedtothePlugDriver
incombinationwiththeTorqueStabilizermustbeusedto
firsttoremovetheHelicalFlange®Plugs.
Figure99:PlugRemoval
NOTE:WhenremovingpreviouslytightenedHelicalFlange®
Plugs,turntheFixedT-Handleinaslightlyclockwise
directionbeforeturningcounterclockwise.Continue
withthisbackandforthmotionuntilthePlugloosens.
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OncetheScrewInserteristightened,theScrewmaybe
backedoutofthepedicle.
Figure100:UsetheScrewInsertertoremovetheScrew
ToremoveascrewshaftutilizetheScrewShaftRemover.
Figure101:ScrewShaftRemover
PositiontheScrewShaftRemoversecurelyovertheimplant
androtatecounterclockwise.
TheButtonLockScrewInserterisusedtoremovethe
Multi-axialScrewsbyseatingthemalepentalobeendinto
thefemalepentalobeatthetopoftheScrewshaft.Rotate
theknurledbarrelinaclockwisedirectiontothreadtheouter
shaftintotheseat.Completelyloadtheoutershaftintothe
seat.SecureitinplacebypushingtheSliderdistally,as
indicatedbythearrow.ConfirmthattheScrewisstraightand
secureintheInserter.
Section 6: Additional Surgical Options (Continued)
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Section 7: Closure, Post Operative Care Section 8: Indications for Use
AfterimplantationofthePolaris™Translation™Screwsis
complete,woundclosureisperformedaccordingtothe
standardprotocolforthesurgeon.
ThePolaris™SpinalSystemisanon-cervicalspinalfixation
deviceintendedforimmobilizationandstabilizationas
anadjuncttofusionasapediclescrewfixationsystem,a
posteriorhookandsacral/iliacscrewfixationsystem,oras
ananteriororanterolateralfixationsystem.Pediclescrew
fixationislimitedtoskeletallymaturepatientsandforuse
withautograftand/orallograft.Thedeviceisindicatedfor
allthefollowingindications:degenerativediscdisease
(definedasdiscogenicbackpainwithdegenerationof
thediscconfirmedbyhistoryandradiographicstudies),
spondylolisthesis,trauma,(i.e.,fractureordislocation),
deformityorcurvature(i.e.,scoliosis,kyphosis,and/or
lordosis),tumor,stenosis,pseudoarthrosis,orfailed
previousfusion.
ThePolaris™SpinalSystemmaybeusedwiththeinstruments
intheAccuVision®MinimallyInvasiveSpinalExposure
Systemtoprovidethesurgeonwithaminimallyinvasive
approachforposteriorspinalsurgery.
ThedominosinthePolaris™SpinalSystemcanbeusedto
connectthePolaris™SpinalSystemtotheAltius™Spinal
System,Lineum™OCTSpineSystem,theArray®Spinal
System,theBiomet ®Omega21™SpinalSystem,orthe
Synergy™SpinalSystemtoachieveadditionallevelsof
fixation.Pleaserefertotheindividualsystem’sPackage
Insertforalistoftheindicationsforuseforeachsystem.
Contraindications
1. Spinalinfection
2. Morbidobesity
3. Apatientwhointhesurgeon’sopinionisnot
psychosocially,mentallyorphysicallyabletofully
complywiththepost-operativetreatmentregime
(e.g.,mentalillness,alcoholismordrugabuse.)
4. Pregnancy
5. Metalsensitivity/foreignbodysensitivity
6. Patientswithinadequatetissuecoverageoverthe
operativesite
7. Openwoundslocaltotheoperativearea
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Warnings
1. Thesafetyandeffectivenessofpediclescrewspinal
systemshavebeenestablishedonlyforspinalconditions
withsignificantmechanicalinstabilityordeformity
requiringfusionwithinstrumentation.Theseconditions
aresignificantmechanicalinstabilityordeformityofthe
thoracic,lumbar,andsacralspinesecondarytosevere
spondylolisthesis(grades3and4)oftheL5-S1vertebra,
degenerativespondylolisthesiswithobjectiveevidence
ofneurologicimpairment,fracture,dislocation,scoliosis,
kyphosis,spinaltumor,andfailedpreviousfusion
(pseudarthrosis).Thesafetyandeffectivenessofthese
devicesforanyotherconditionsareunknown.Potential
risksidentifiedwiththeuseofthisdevice,whichmay
requireadditionalsurgery,includedevicecomponent
fracture,lossoffixation,non-union,fractureofthe
vertebra,neurologicalinjury,andvascularor
visceralinjury.
2. ImplantStrengthandLoading.ThePolaris™Spinal
Systemisintendedtoassisthealingandisnotintended
toreplacenormalbonystructures.Loadsproduced
byweightbearingandactivitylevelswilldictatethe
longevityoftheimplant.Thesedevicesarenotdesigned
towithstandtheunsupportedstressoffullweightbearing
orloadbearing,andcannotwithstandactivitylevels
and/orloadsequaltothoseplacedonnormalhealthy
bone.Ifhealingisdelayedordoesnotoccur,theimplant
couldeventuallybreakduetometalfatigue.Therefore,
itisimportantthatimmobilizationoftheoperativesite
bemaintaineduntilfirmbonyunion(confirmedby
clinicalandradiographicexamination)isestablished.
Thesurgeonmustbethoroughlyknowledgeableinthe
medical,surgical,mechanicalandmetallurgicalaspects
ofthePolaris™SpinalSystem.Postoperativecareis
extremelyimportant.Thepatientshouldbewarnedthat
noncompliancewithpostoperativeinstructionscould
leadtobreakageoftheimplantand/orpossiblemigration
requiringrevisionsurgerytoremovetheimplant.
3. SelectionofImplants.Selectionofthepropersize,
shapeanddesignoftheimplantincreasesthepotential
forsuccess.Whileproperselectioncanhelpminimize
risks,thesizeandshapeofhumanbonespresentsize
limitationsontheimplants.
4. Metabolicbonediseasesuchassevereosteoporosismay
adverselyaffectadequatefixationoftheimplantsdueto
thepoorqualityofthebone.
5. Thesurgeonmustensurethatallnecessaryimplantsand
instrumentsareonhandpriortosurgery.Theymustbe
handledandstoredcarefully,protectedfromdamage,
includingfromcorrosiveenvironments.Theyshouldbe
carefullyunpackedandinspectedfordamagepriorto
use.Allnonsterilecomponentsandinstrumentsmustbe
cleanedandsterilizedbeforeuse.
BiometSpineimplantsshouldnotbeusedwithimplants
orinstrumentsfromanothermanufacturerforreasonsof
metallurgy,mechanicsanddesign.
6. Corrosion.Contactofdissimilarmetalsacceleratesthe
corrosionprocess,whichcouldincreasethepossibilityof
fatiguefractureoftheimplants.Therefore,onlyuselike
orcompatiblemetalsforimplantsthatareincontactwith
eachother.Neverusestainlesssteelandtitaniumimplant
componentsinthesameconstruct.
CobaltChromeAlloyrodsshouldnotbeusedwith
StainlessSteelComponents.CobaltChromeAlloyrods
aretobeusedONLYwithtitaniumimplantcomponents
inthesameconstruct.
7. ThePolaris™SpinalSystemhasnotbeenevaluatedfor
safetyandcompatibilityintheMRenvironment.The
Polaris™SpinalSystemhasnotbeentestedforheatingor
migrationintheMRenvironment.
Limits of System Compatibility
WhenusedwiththeAccuVision®Instruments,thesystemis
limitedtotheimplantationofrodlengthsof100mmorless,
andexcludestheuseofsystemcrossconnectorsorhooks.
Section 8: Indications for Use (Continued)
Page 35
33
Precautions
1. Donotreuseimplants.Whileanimplantmayappear
undamaged,previousstressmayhavecreated
imperfectionsthatwouldreducetheservicelife
oftheimplant.Donottreatpatientswithimplants
thathavebeenevenmomentarilyplacedinorused
onadifferentpatient.
2. HandlingofImplants.Ifcontouringoftherodisrequired,
avoidsharpbendsandreversebends.Avoidnotchingor
scratchingofthedevice,whichcouldincreaseinternal
stressesandleadtoearlybreakage.
3. ImplantRemovalAfterHealing.Afterhealingiscomplete,
theimplantisintendedtoberemovedsinceitisno
longernecessary.Implantsthatarenotremovedmay
resultincomplicationssuchasimplantloosening,
fracture,corrosion,migration,painorstressshielding
ofbone,particularlyinyoung,activepatients.Implant
removalshouldbefollowedbyadequate
postoperativemanagement.
4. AdequatePatientInstructions.Apatientmustbe
instructedonthelimitationsofthemetallicimplant,
andshouldbecautionedregardingphysicalactivityand
weightbearingorloadbearingpriortocompletehealing.
5. SurgicalTechniques.Theimplantationofpediclescrew
spinalsystemsshouldbeperformedonlybyexperienced
spinalsurgeonswithspecifictrainingintheuseofthis
pediclescrewspinalsystembecausethisisatechnically
demandingprocedurepresentingariskofserious
injurytothepatient.Pleaserefertothespecificsurgical
techniqueforthisdeviceformoreinformation.
6. TheAdjustableLengthRodisintendedforinsitu
adjustmentafterplacementofthehooksorscrews
duringspinalfusionsurgeryandisintendedforuseas
partofeitherasingleordoublerodassembly.Itallows
fordistractionatacentrallocationonceboneanchors
havebeensecured.
7. TheBulletEndRodsareintendedforusewiththe
JacksonIntrasacralFixationTechnique.
Sterilization Information
ThePolaris™SpinalSystemisprovidednonsterileandmust
besterilizedpriortouse.Allinstrumentcomponentsshould
besterilizedinaloosenedstatesuchthatcomponentsmay
movefreely.Allpackagingmaterialsmustberemovedprior
tosterilization.Thefollowingsteamsterilizationparameters
arerecommended.
U.S. Sterilization Parameters:
Cycle: HighVacuum
Temperature: 270°F/132°C
Time: 4minutes
DryingTime: 30minutes
NOTE: Allow for cooling
Sterilization Parameters for Use Outside the U.S.:
Cycle: Pre-vacuumSteam
Temperature: 275°F/135°C
Time: 3minutes
DryingTime: 30minutes
NOTE: Allow for cooling
FDAclearedsterilizationwrapsshouldbeusedtomaintain
sterilityafterprocessing.
Biometdoesnotrecommendstackingoftraysduringthe
sterilizationprocess.
Individualsnotusingtherecommendedmethod,temperature
andtimeareadvisedtovalidateanyalternativemethodsor
cyclesusinganapprovedmethodorstandard.
Sterilepackagedcomponentsaresterilizedbyexposure
toaminimumdoseof25-kGygammaradiationorbyEtO,
accordingtoindividualcomponentlabeling.Components
labeledforsingleuseonlycannotbere-sterilized.Donotuse
ifpackagehasbeencompromised.
Pleaseseethepackageinsertforadditionalinformationon
thesystem.
Page 36
34
Section 9: Ordering Information
Polaris™ Translation™ Screw Standard Implant Kit
Catalog Number: 14-509669
Catalog # Description Qty.
14-500070 Polaris™5.5ButtonLockScrewInserter
2
14-500071 TranslatingScrewBonePlaner 1
14-500085 Double-LeadTap,4mm 1
14-500086 Double-LeadTap,4.75mm 1
14-500088 Double-LeadTap,5.5mm 1
14-500089 Double-LeadTap,6.5mm 1
14-500090 Double-LeadTap,7.5mm 1
14-578325 5.5Ti5.5x25mmTranslation 2
14-578330 5.5Ti5.5x30mmTranslation 6
14-578335 5.5Ti5.5x35mmTranslation 8
14-578340 5.5Ti5.5x40mmTranslation 8
14-578345 5.5Ti5.5x45mmTranslation 8
14-578350 5.5Ti5.5x50mmTranslation 4
14-578355 5.5Ti5.5x55mmTranslation 2
14-578430 5.5Ti6.5x30mmTranslation 4
14-578435 5.5Ti6.5x35mmTranslation 6
14-578440 5.5Ti6.5x40mmTranslation 8
14-578445 5.5Ti6.5x45mmTranslation 8
14-578450 5.5Ti6.5x50mmTranslation 8
14-578455 5.5Ti6.5x55mmTranslation 6
14-578530 5.5Ti7.5x30mmTranslation 4
14-578535 5.5Ti7.5x35mmTranslation 6
14-578540 5.5Ti7.5x40mmTranslation 8
14-578545 5.5Ti7.5x45mmTranslation 8
14-578550 5.5Ti7.5x50mmTranslation 8
14-578555 5.5Ti7.5x55mmTranslation 6
Polaris™ Translation™ Screw Standard Implant Kit
Catalog Number: 14-509669 (Continued)
Catalog # Description Qty.
2000-1005 Plug 30
2000-1020 LateralConnector,Open,25mm 2
2000-5130 30mmTiAlloyCurvedRod 4
2000-5135 35mmTiAlloyCurvedRod 4
2000-5140 40mmTiAlloyCurvedRod 4
2000-5145 45mmTiAlloyCurvedRod 4
2000-5150 50mmTiAlloyCurvedRod 4
2000-5155 55mmTiAlloyCurvedRod 4
2000-5160 60mmTiAlloyCurvedRod 4
2000-5165 65mmTiAlloyCurvedRod 4
2000-5170 70mmTiAlloyCurvedRod 4
2000-5175 75mmTiAlloyCurvedRod 4
2000-5180 80mmTiAlloyCurvedRod 4
2000-5190 90mmTiAlloyCurvedRod 4
2000-5199 100mmTiAlloyCurvedRod 4
2000-5405 510mmTiAlloyRodwithHex 2
94669 XXSmallCrossConnector 2
94670 XSmallCrossConnector 2
94671 SmallCrossConnector 2
94672 MediumCrossConnector 2
94673 LargeCrossConnector 2
Page 37
35
Polaris™ Translation™ Screw Iliac Implant Kit
Catalog Number: 14-509668
Catalog # Description Qty.
14-500073 ScrewShaftRemover 1
14-500191 Double-LeadIliacTap,5.5mm 1
14-500192 Double-LeadIliacTap,6.5mm 1
14-500193 Double-LeadIliacTap,7.5mm 1
14-500194 Double-LeadIliacTap,8.5mm 1
14-500097 Double-LeadIliacTap,9.5mm 1
14-500098 Double-LeadIliacTap,10.5mm 1
14-578460 6.5x60mmScrew 4
14-578470 6.5x70mmScrew 4
14-578480 6.5x80mmScrew 2
14-578490 6.5x90mmScrew 2
14-578560 7.5x60mmScrew 4
14-578570 7.5x70mmScrew 4
14-578580 7.5x80mmScrew 4
14-578590 7.5x90mmScrew 4
14-578599 7.5x100mmScrew 2
14-578635 8.5x35mmScrew 4
14-578640 8.5x40mmScrew 4
14-578645 8.5x45mmScrew 4
14-578650 8.5x50mmScrew 4
14-578655 8.5x55mmScrew 4
14-578660 8.5x60mmScrew 4
14-578670 8.5x70mmScrew 4
14-578680 8.5x80mmScrew 4
14-578690 8.5x90mmScrew 4
14-578699 8.5x100mmScrew 2
Polaris™ Translation™ Screw 4.75 Implant Kit
Catalog Number: 14-509682
Catalog # Description Qty.
14-578225 5.5Ti4.75x25mmTranslation 4
14-578230 5.5Ti4.75x30mmTranslation 6
14-578235 5.5Ti4.75x35mmTranslation 6
14-578240 5.5Ti4.75x40mmTranslation 6
14-578245 5.5Ti4.75x45mmTranslation 2
Polaris™ 5.5 Standard Instrument Kit A
Catalog Number: 14-509680
Catalog # Description Qty.
14-500980 SurgicalTray,Standard 1
124797 RatchetingScrewInserter 1
124799 RatchetingScrewInserter 2
14-500001 ThoracicPedicleProbe 1
14-500002 StraightLumbarPedicleProbe 1
14-500003 CurvedLumbarPedicleProbe 1
14-500007 FirmPedicleSound 1
14-500018 TorqueStabilizer 1
14-500072 ScrewHeadPositioner 1
14-500170 PlugStarterWithFixedHandle 2
14-500185 Multi-axialScrewInserter 2
14-500197 Polaris™5.5Rocker,ExtThrow 1
14-501680 DorsalHeightAdjuster 1
2000-6481 RatchetingTearDropHandle 1
2000-9015 FlexiblePedicleSound 1
2000-9023 4.75mmTap 1
2000-9024 5.5mmTap 1
2000-9025 6.5mmTap 1
2000-9026 7.5mmTap 1
2000-9027 8.5mmTap 1
2000-9061 PlugDriver 2
94505 PedicleAwl-QCShaft 1
94522 QCTorqueWrenchHandle 2
94613 RodHolder 1
Page 38
36
Section 9: Ordering Information (Continued)
ThePolaris™Translation™ScrewSystemiscompatiblewith
thekitsutilizedbythePolaris™5.5SpinalSystem.
Catalog # Description
14-509605 ReductionMulti-axialScrewKit
14-509606 4.75mmMulti-axialScrewKit
14-509607 8.5mmMulti-axialScrewKit
14-509629 4mmDiameterScrewkit
14-509630 TitaniumDeformityFixedScrewImplantKit
14-509631 TitaniumDeformityHookImplantKit
14-509632 TitaniumDeformityStandardInstrumentKitA
14-509633 TitaniumDeformityStandardInstrumentKitB
14-509634 Trivium™DerotationKit
14-509635 IliacFixationKit
14-509636 UniplanarScrewKit
14-509637 PerpendicularPersuaderKit
14-509638 LongThreadedReductionInstrumentKit
14-509639 ShortThreadedReductionInstrumentKit
14-509660 CobaltChromeImplantKit
14-509661 TiDominoStandardImplantandInstrumentKit
Polaris™ 5.5 Standard Instrument Kit B
Catalog Number: 14-509681
Catalog # Description Qty.
14-500009 ReductionScrewBreak-OffTool 1
14-500198 PerpendicularRodPersuader 1
2000-9044 RodBender 1
94624 CrossConnectorTorqueWrench 1
94686 ParallelCompressor 1
94687 ParallelDistractor 1
Page 39
37
Further Information
Thisbrochuredescribesasurgicaltechniqueusedby
SabatinoBianco,M.D.,FAANSandPaulSuh,M.D.The
surgeonwhoperformsanyimplantprocedureisresponsible
fordeterminingtheappropriateproduct(s)andutilizing
theappropriatetechnique(s)forsaidimplantationineach
individualpatient.Thecontentsofthismanualareintendedto
beonlyaguideandarenotintendedtosetastandardofcare.
HelicalFlange®isaregisteredtrademarkof
RogerP.Jackson.
TheCrossbar™CrossConnectorwasdevelopedby
SeaSpine,Inc.CrossbarisatrademarkofSeaSpine,Inc.
CAUTION:FederalLaw(USA)restrictsthisdevicetosaleby
orontheorderofaphysician.
Allcontenthereinisprotectedbycopyright,trademarksand
otherintellectualpropertyrightsownedbyorlicensedto
BiometInc.oritsaffiliatesunlessotherwiseindicated,and
mustnotberedistributed,duplicatedordisclosed,inwhole
orinpart,withouttheexpresswrittenconsentofBiomet.
Thismaterialisintendedforhealthcareprofessionalsand
theBiometsalesforce.Distributiontoanyotherrecipient
isprohibited.
Forcompleteproductinformation,includingindications,
contraindications,warnings,precautions,andpotential
adverseeffects,seethepackageinsert.
Thistechniquewaspreparedinconjunctionwithalicensed
healthcareprofessional.Biometdoesnotpracticemedicine.
Thetreatingsurgeonisresponsiblefordeterminingthe
appropriatetreatment,technique(s),andproduct(s)foreach
individualpatient.
Forfurtherinformation,pleasecontacttheCustomerService
Departmentat:
BiometSpine
310InterlockenParkway,Suite120,
Broomfield,CO80021
303.443.7500•800.447.3625
biometspine.com
Page 40
Broomfield,CO•800.447.3625•biometspine.com•BSP231120L.0105/14©2014BiometSpine,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.,oroneof
itssubsidiaries,unlessotherwiseindicated.TheCrossbar™CrossConnectorwasdevelopedbySeaSpine,Inc.CrossbarisatrademarkofSeaSpine,Inc.HelicalFlange®isaregisteredtrademarkofRogerP.Jackson.RxOnly.
AtBiomet,engineeringexcellenceisourheritageand
ourpassion.Forover25years,throughvarious
divisionsworldwide,wehaveappliedthemost
advancedengineeringandmanufacturingtechnology
tothedevelopmentofhighlydurablesystemsfora
widevarietyofsurgicalapplications.
Tolearnmoreaboutthisproduct,
contactyourlocalBiometSalesRepresentativetoday.
Polaris™ System Translation™ Screw