Polaris System Translation Screw - Zimmer Biomet...The ™Polaris Translation™ Screw System is compatible with the implant offering of the Polaris™ 5.5 Spinal System. Figure 3:

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

B

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

1

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.

2

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

3

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

4

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.

5

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

6

Instruments (Continued)

Figure18:RatchetHandle-T

Figure19:FixedTeardropHandle

Figure20:RatchetTeardropHandle

Figure21:AwlShaft


theinstrumentofferingofthePolaris™5.5SpinalSystem.

Figure15:FixedHandle-T

Figure16:FixedHandle-Straight

Figure17:RatchetHandle-Straight

7

Figure26:StiffPedicleSound

Figure27:FlexiblePedicleSound

Figure28:TrialPins

Figure29:Multi-axialScrewInserter

Figure22:ThoracicPedicleProbe

Figure23:StraightPedicleProbe

Figure24:CurvedPedicleProbe

Figure25:SingleLeadTap

8


Figure34:TeardropPlugInserter

Figure35:DoubleEndPlugStarter

Figure36:RodRocker

Figure37:ShortRocket™ThreadedReducer

Figure30:DorsalHeightAdjuster

Figure31:RodTemplate

Figure32:RodHolder

Figure33:RodBender

9

Figure42:PerpendicularRodPersuader

Figure43:SoftTissueRetractor

Figure44:Compressor

Figure45:Distractor

Figure38:LongRocket™ThreadedReducer

Figure39:OffsetT-Handle

Figure40:OffsetT-Handle

Figure41:QCAdaptor

10


Figure50:TorqueStabilizer

Figure51:ReductionScrewBreak-OffStabilizer

Figure52:ReductionScrewBreak-OffPliers

Figure46:CrossConnectorTorqueWrench

Figure47:TorqueLimitingWrench.AssembledfromPlug

DriverandTorqueLimitingHandle.

Figure48:PlugDriver

Figure49:TorqueLimitingHandle

11

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.

12

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)

13

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

14

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

15

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.

16

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)

17

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

18

Long Rocket™ Threaded Reducer

Tofacilitateattachment,ensurethatthelasermarkedline

iswithinthetwolasermarkedlinesandalignedtothe

“ATTACH”textontheshaftoftheReducerandaredproximal

bandisvisible.AttachtheLongRocket™ThreadedReducer

bypositioningthespringloadedarmsintothematingScrew

seatgeometry.Theinternalstopensuresproperpositioning.


19

Figure76:Rodreduction

Figure74:AttachmentofLongRocket™ThreadedReducer






20

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


21

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

22

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

23

TheTorqueLimitingWrenchisturnedinaclockwise

directionwhiletheTorqueStabilizerisfirmlyheldwith

resistiveforceinacounterclockwisedirection.TheTorque

LimitingWrenchshouldbeturneduntilanaudibleclickis

heardandatactileindicationfelt,confirmingproperfinal

tighteningbyapplying110in-lbs.oftorque.

.

Figure84:FinalTightening

NOTE:UsetheTorqueLimitingWrenchincombinationwith

theTorqueStabilizerforproperfinaltighteningoftheHelical

Flange®Plugs.

24

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

25

Figure86:AttachmentofLongRocket™Reducer






Figure88:Rodreduction

26

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)

27

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

28

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)

29

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.

30

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)

31

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

32

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)

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.

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




14-578325 5.5Ti5.5x25mmTranslation 2



















Polaris™ Translation™ Screw Standard Implant Kit

Catalog Number: 14-509669 (Continued)


2000-1005 Plug 30

2000-1020 LateralConnector,Open,25mm 2

2000-5130 30mmTiAlloyCurvedRod 4













2000-5405 510mmTiAlloyRodwithHex 2

94669 XXSmallCrossConnector 2

94670 XSmallCrossConnector 2

94671 SmallCrossConnector 2

94672 MediumCrossConnector 2

94673 LargeCrossConnector 2

35

Polaris™ Translation™ Screw Iliac Implant Kit



14-500073 ScrewShaftRemover 1

14-500191 Double-LeadIliacTap,5.5mm 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








Polaris™ 5.5 Standard Instrument Kit A



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

36

Section 9: Ordering Information (Continued)


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



14-500009 ReductionScrewBreak-OffTool 1

14-500198 PerpendicularRodPersuader 1

2000-9044 RodBender 1

94624 CrossConnectorTorqueWrench 1

94686 ParallelCompressor 1

94687 ParallelDistractor 1

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

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

Documents

Polaris System Translation Screw - Zimmer Biomet...The ™Polaris Translation™ Screw System is compatible with the implant offering of the Polaris™ 5.5 Spinal System. Figure 3: