Spine

Radius®

Surgical Technique

Precision

•Zoneoflockingsecurity•Non-threadedlockingmechanism•Simple,lowtorqueclosure•Lowprofile,lowvolumemulti-anglescrew

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Important:TheRadius®implantsandinstrumentsaredesignedandtestedforuseonlywiththeRadius®SpinalSystem.Thissurgicaltechniquesetsforthdetailed,recommendedproceduresforusingtheRadius®PrecisionSystemimplantsandinstruments.Itoffersguidancethatyoushouldheedbut,aswithanysuchtechnicalguide,eachsurgeonmustconsidertheparticularneedsofeachpatientandmakeappropriateadjustmentswhennecessaryandasrequired.

Note:This is intended as a guide only. There are multiple techniques for the insertion of pedicle screws and, as with any surgical procedure, a surgeon should be thoroughly trained before proceeding.

Minimallyinvasivesystemshavebeendesignedtoreducetissuetraumathroughsmallerincisions.TheRadius®PrecisionSystemforminimallyinvasivesurgerycontainscannulatedscrewsthathavebeendevelopedtofacilitatescrewimplantationduetothereducedvisualizationwithinthesenarrowerworkingchannels.

TheRadius®PrecisionSystemhelpssurgeonsimplanttheRadius®cannulatedpolyaxialtitaniumscrewsthroughalessinvasiveposteriorapproachbyfollowingthepathofaguidewire.Thisisaccomplishedwithstreamlinedinstrumentationdesignedtomaximizevisualizationwhileminimizingthecomplexityofthesystem.

Introduction

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Table of Contents

Precision Surgical Technique

Introduction 02

Key Design Features 04

I. Pedicle Preparation 06

II. Screw Insertion 12

III. Rod Insertion 14

IV. Final Tightening 15

Implants 16

Instruments 17

Low profile screw head designed to enhance visualization of the anatomy

Follows pathof K-Wire

Color coded

40˚ polyaxial freedom

35˚ tip

3 cutting flutesfacilitate boneinsertion

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Radius® Precision ScrewBiomechanical Strength

• Equivalentstrengthtonon-cannulatedscrewunderstaticcorpectomyconditions*

• TitaniumAlloy(Ti6Al4V)

Self-Tapping Screw

ScrewSizes:Ø5.75x35-50mm(5mmincrements)Ø6.75x30-55mm(5mmincrements)Ø7.75x30-55mm(5mmincrements)

Radius® Locking Cap

Ø5.5mm Pre-Cut / Pre-Bent Rods

• Shortlengthswithtightbendforsinglelevelfusions

• Mediumlengthswithgradualbendfor1and2levelfusions

• Longerlengthstoaccommodate2and3levelfusions

• TitaniumAlloy(Ti6Al4V)

*DataonfileatStryker®Spine:EngineeringAnalysisK060705

Key Design Features - Implants

Safety

• Depthmarkingsonguidewirearedesignedtoproviderealtimefeedbacktominimizesurgicalandfluoroscopytime.

Note:TheRadius®K-Wireis1.5mmindiameterandisspecificallydesignedforusewiththeRadius®PrecisionSystem.

Note:TheRadius®K-WirediffersfromtheXia®/MANTIS®K-Wire.Radius®K-WiremeasuresØ1.5mmwhiletheXia®/MANTIS®K-WireisØ1.3mm.

10mm increments between markings

1010101010

Streamlined Instruments

• Reducedinstrumentprofilesaredesignedtomaximizevisualizationforminimally-invasiveprocedures.

• Allinstrumentsarecannulatedtoalloweasyplacementovertheguidewire.

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Key Design Features - Instruments

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Aspinalneedle,JamShidi,ispositionedontheskindirectlyoverthepedicleusinganA/Pimage.

Note: TheJamShidiisasingleuseinstrument,whichisprovidedsterile.

I. Pedicle Preparation

TheJamShidiisthenmoved1to2cmlateraltothemarkingsandinsertedthroughtheskintotheintersectionofthefacetandtransverseprocess.

BothA/Pandlateralimagesconfirmthattheappropriatestartingplacehasbeendetermined.

TheJamShidineedleisusedtogainaccesstothepedicle.AfterplacingtheJamShidiattheintersectionofthefacetandthetransverseprocess,theneedlemaybeadvancedpartiallythroughthepedicleusingtheSlapHammer.

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WhentheneedlereachesthemedialwallontheA/Pview,verificationshouldbeperformedinthelateralviewtoensuretheneedleispastthebaseofthepedicle.

I. Pedicle Preparation

AsthepedicleisnavigatedwiththeJamShidi,itshouldapproachthemedialwallofthepedicleontheA/Pviewandshouldapproachthebaseofthepedicleonthelateralview.

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TheinnertrocaroftheJamShidiisremoved.

I. Pedicle Preparation

TheremovaloftheJamShidiinnertrocarallowstheK-Wire(SharporBlunt)tobeinsertedintothepedicle.

CautionmustbepracticedwithregardtothepositionoftheK-WireinordertoavoidadvancementoftheK-Wire.

Note:TheRadius®K-Wireis1.5mmin

diameter.TheMANTIS®andXia®K-Wireis1.3mmindiameter.

Note:TheK-Wireisasingleuseinstrument.

TheK-WireGuideTubecanbeusedtopreventtheK-Wirefrombendingormovingduringinsertion.PlacetheK-WireGuideTubeovertheK-WireanddockitontheJamShidi.

TheSlapHammercanthenbeusedtoimpacttheK-Wire.

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ThepedicleispreparedbyplacingtheCannulatedPedicleAwlovertheK-Wireandtwistingitintothepedicle.

HoldtheK-WireinpositionwhenremovingtheAwl.

UsethecannulatedSlapHammertoimpacttheAwl.

Note:TheCannulatedPedicleAwlhasastopat12.0mm.

I. Pedicle Preparation

OncetheK-Wireisinserted,theoutershaftoftheJamShidimayberemoved.

HoldtheK-WireinpositionwhenremovingtheJamShidi.

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Iftheboneistoohard,theappropriateCannulatedTapmaybeusedtopreparethepediclescrewcanal.

TheRadius®CannulatedTapsarelaseretchedwith10mmintervalstohelpindicatethedepthatwhichtheCannulatedTaphasbeeninsertedaswellastohelpdetermineproperscrewlength.

TheCannulatedTapshavebeencoloredgoldupto40mmtoallowforeasyvisualizationof40mmdepth,whichrepresentsthemostcommonscrewlength.

Note:ThelengthoftheCannulatedTapthreadis25mm.

I. Pedicle Preparation

Note: The1cmintervalmarkingsontheK-Wireprovidethecannulatedinstrument’s

depthinthepedicle.

Asaninstrumentadvancesintothepedicle,theproximalendoftheinstrumentwillmoverelativetothemarkings.IfthisdoesnotoccurduringinsertiontheprocedureshouldbestoppedandfluoroscopyshouldbeusedtoverifythepositionoftheK-WireinrelationtotheAwlorTap.

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I. Pedicle Preparation

TheTapSleevecanbeusedtopreventsofttissuefromcontactingthethreadsoftheTap.

CheckpedicledepthwitheitherfluoroscopyorreadthedepthfromtheTapSleeveasitmovesalongtheproximalshaftoftheTap.Therearemarkingsat30,40,and50mm.

Note:TheTapSleeveismadeofradiolucentUltemPolyEtherImide.

Note:SlidetheTapSleeveproximaltothe

tapshafttoengagethefrictionfit.

HoldtheK-WireinpositionwhenremovingthePrecisionTap.

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Withthepediclepathwayspreparedandproperscrewlengthanddiameterdetermined,thescrewisreadyforinsertion.

TheRadius®CannulatedMulti-AngleScrewInserterisdesignedtoprovidearigidconnectionbetweenthepolyaxialscrewandthescrewdriver.Thescrewdrivercanbeattachedtoanyofthecannulatedmodularhandlesusingthequickreleasemechanism.

Cannulated Multi-Angle Screws

ToassembletheCannulatedMulti-AngleScrewInserter:1.InserttheinnershaftthroughthebodyoftheCannulatedMulti-AngleScrewInserter.2.InserttheratchetdowntheshaftoftheCannulatedMulti-AngleScrewInserter.Verifythattheratchetisbottomedout.3.Connecttothedesiredhandle.4.EnsurethattheCannulatedMulti-AngleScrewInserterisfullyunlocked.5.AlignthetabsontheCannulatedMulti-AngleScrewInsertershaftwiththeexternalquadonthescrewheadwhileholdingthebonescrew.6.RotatethedialontheCannulatedMulti-AngleScrewInserterclockwisetofirmlyseatthescrewontotheCannulatedMulti-AngleScrewInserter.

II. Screw Insertion

Step 1

Step 2

Step 3

Step 4

Cannulated Multi-Angle Screw Inserter

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TheRadius®PrecisionScrewisthenplacedovertheK-Wireandinsertedintothepedicle.

II. Screw Insertion

Afterdrivingthescrewintothepedicle,removetheK-Wiretopreventitfromadvancing.

Becertainthatthescrewisnotinsertedtoofar.Ifthemulti-axialheadoftheRadius®PrecisionScrewisdriventooforcefullyagainstbone,itwillloseitsmulti-axialcapabilitiesmakingitdifficulttoconnecttheassembliesduringsubsequentsteps.

Oncethescrewisinsertedintothepedicle,pushthegoldbuttonandrotatethedialontheMulti-AngleScrewInsertercounter-clockwiseuntiltheCannulatedMulti-AngleScrewInserterisloosefromthescrew.

RemovetheCannulatedMulti-AngleScrewInserterfromthescrew.

Theprocessisrepeatedforadditionalscrews.

Afterinsertingbothscrews,theheadofthescrewsshouldbethesameheight.

Note:TheCannulatedMulti-AngleScrew

Insertercanbeusedfortheremovalof

CannulatedScrews.

IV. Final Tightening

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AfterverifyingwithA/P,lateral,andobliqueviewsthattherodisseatedintheheadsofbothscrews,theLockingCapmustbeinsertedintothescrewheadusingtheInitialInserter.ApplydownwardpressuretoensuretheLockingCapisfirmlyseatedagainsttherod,thenturntheLockingCaptoitsprovisionallylockedposition.TheLockingCapisprovisionallylockedwhenthelaseretchedlinesontheLockingCapareparalleltotherod.

Note:TheInitialInserterTubecanbeusedtoguidetheLockingCapintothescrewhead.

Tip:Itisrecommendedtobeginclosureattheeasiestpointintheconstruct.Thismayhelpfacilitatetheseatingoftherodinadjacentimplants.

Whenarodthatissittingslightlyproudisforceddownduringtightening,ensurethatthelockingcapisfullyengagedintothescrewhead.Thiswillhelpresistthehighreactiveforcesgeneratedduringfinaltightening.

Extra caution is advised when:1. Therodisnothorizontallyplaced intothescrewhead.2. Therodishighinthescrewhead.3. Anacuteconvexorconcavebend iscontouredintotherod.

III. Rod Insertion

Oncetherodisbenttothedesiredcontour,itisplacedintothetulipheadsofthescrewusingarodinserter.

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IV. Final Tightening

Oncethecorrectionprocedureshavebeencarriedoutandthespineisfixedinasatisfactoryposition,thefinaltighteningoftheLockingCapsisdonebyutilizingtheCounterTorqueTubeandtheFinalDriver.

1. PlacetheCounterTorqueTube aroundthescrewheadandover therod.

2. PlacetheFinalDriverintothestar ontheLockingCapbyfirstaligning thelinesontheFinalDrivershaft withthelinesontheLockingCap.

3. TwisttheFinalDriveruntilthe handleoftheFinalDriveris perpendiculartothehandleofthe CounterTorqueTubeoruntilthe FinalDrivernolongertwists.The lasermarkedlinesontheLocking Capshouldbewithinthe lasermarkedzoneonthescrewhead asshowninthefigurebelow.

Tip:ItisimportanttopositiontheCounter

TorqueTubebeforetheFinalDriveris

insertedtominimizetheriskofinstrument

slippage.

Note:TheCounterTorqueTubemustbe

usedforfinaltightening.TheCounter

TorqueTubeisdesignedtoperformthree

importantfunctions:

1. ToaligntheFinalDriverwiththe

tighteningaxis.

2. Tomaximizethetorqueneededtolock

theimplantassembly.

3. Toholdtheconstructinplaceduring

finaltightening.

Applybonegrafttothefusionsiteandcloseintheusualmanner.

Note:Forremovalreversethefinaltighteningsequence.

Par t number Descript ion

486610000 Locking Cap

4866125 (35) - (50)Screw, Multi-Angle, Cannulated Ø5.75 x 35mm-50mm

4866126 (30) - (55)Screw, Multi-Angle, Cannulated Ø6.75 x 30mm-55mm

4866127 (30) - (55)Screw, Multi-Angle, Cannulated Ø7.75 x 30mm-55mm

4866150 (30) - (90)Ø5.5mm Titanium Rad Rod30mm-90mm lengths

4866155 (50) - (80)Ø5.5mm Titanium Max Rad Rod50mm-80mm lengths

Implants

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Par t number Descript ion

486619461 Precision Tray

48237110482371054823711548237135

Jam Shidi 10 Gauge 9 Inch (x6) Jam Shidi 10 Gauge 5 Inch (x6) Jam Shidi 11 Gauge 5 Inch (x6) Jam Shidi 13 Gauge 5 Inch (x6)

486619046486619045

K-Wire BluntK-Wire Sharp

486619055 K-Wire Guide Tube

486619345 Cannulated Pedicle Awl

486619350486619355486619360

Ø5.75mm Cannulated TapØ6.75mm Cannulated TapØ7.75mm Cannulated Tap

486619370 Slap Hammer

48231315 Tap Sleeve

486619090Multi-Angle Screw Inserter Cannulated

486619080 Cannulated T-Handle

486619070 Cannulated T-Ratcheting Handle

486619075 Cannulated Standard Handle

486619065Cannulated Standard Ratcheting Handle

486619215 Initial Inserter

486619220 Initial Inserter Tube

486619235 Counter Torque Tube

486619240 Final Driver

Instruments

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IndicationsTheRadius®SpinalSystemisintendedforuseinthenoncervicalspine.Whenusedasananterior/anterolateralandposterior,noncervicalpedicleandnon-pediclefixationsystem,theRadius®SpinalSystemisintendedtoprovideadditionalsupportduringfusionusingautograftorallograftinskeletallymaturepatientsinthetreatmentofthefollowingacuteandchronicinstabilitiesordeformities:• Degenerativediscdisease(DDD)(definedasbackpainofdiscogenicoriginwithdegenerationofthediscconfirmedby

historyandradiographicstudies);• Spondylolisthesis;• Trauma(i.e.,fractureordislocation);• Spinalstenosis;• Curvature(i.e.,scoliosis,kyphosis,and/orlordosis);• Tumor;• Pseudoarthrosis;and• Failedpreviousfusion.TheRadius®SpinalSystemcanalsobelinkedtotheXia®TitaniumSpinalSystemviatheØ5.5mmtoØ6.0mmRadius®rod-to-rodconnector.

ContraindicationsContraindicationsmayberelativeorabsolute.Thechoiceofaparticulardevicemustbecarefullyweighedagainstthepatient’soverallevaluation.Circumstanceslistedbelowmayreducethechancesofasuccessfuloutcome:• Anyabnormalitypresentwhichaffectsthenormalprocessofboneremodelingincluding,butnotlimitedto,severe osteoporosisinvolvingthespine,boneabsorption,osteopenia,primaryormetastatictumorsinvolvingthespine,active infectionatthesiteorcertainmetabolicdisordersaffectingosteogenesis.• Insufficientqualityorquantityofbonewhichwouldinhibitrigiddevicefixation.• Previoushistoryofinfection.• Excessivelocalinflammation.• Openwounds.• Anyneuromusculardeficitwhichplacesanunusuallyheavyloadonthedeviceduringthehealingperiod.• Obesity.Anoverweightorobesepatientcanproduceloadsonthespinalsystemwhichcanleadtofailureofthe fixationofthedeviceortofailureofthedeviceitself.• Patientshavinginadequatetissuecoverageoftheoperativesite.• Pregnancy.• Aconditionofsenility,mentalillness,orsubstanceabuse.Theseconditions,amongothers,maycausethe patienttoignorecertainnecessarylimitationsandprecautionsintheuseoftheimplant,leadingtofailure,or othercomplications.• Foreignbodysensitivity.Wherematerialsensitivityissuspected,appropriatetestsshouldbemadepriorto materialselectionorimplantation.• Othermedicalorsurgicalconditionwhichwouldprecludethepotentialbenefitofspinalimplantsurgery,such asthepresenceoftumors,congenitalabnormalities,elevationofsedimentationrateunexplainedbyother diseases,elevationofwhitebloodcellcount(WBC),ormarkedleftshiftintheWBCdifferentialcount.Thesecontraindicationscanberelativeorabsoluteandmustbetakenintoaccountbythephysicianwhenmakingadecision.Theabovelistisnotexhaustive.

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Cautions and WarningsCAUTIONS (U.S.A.)Federallaw(U.S.A)restrictsthisdevicetosalebyorontheorderofalicensedphysician.Theimplantationofpediclescrewspinalsystemsmustbeperformedonlybyexperiencedspinalsurgeonswithspecifictrainingintheuseofthispediclescrewspinalsystembecausethisisatechnicallydemandingprocedurepresentingariskofseriousinjurytothepatient.Basedonthefatiguetestingresults,thephysician/surgeonmustconsiderthelevelsofimplantation,patientweight,patientactivitylevel,otherpatientconditions,etc.,whichmayimpactontheperformanceofthesystem.

WARNING (U.S.A.)Thesafetyandeffectivenessofpediclescrewspinalsystemshavebeenestablishedonlyforspinalconditionswithsignificantmechanicalinstabilityordeformityrequiringfusionwithinstrumentation.Theseconditionsaresignificantmechanicalinstabilityordeformityofthethoracic,lumbar,andsacralspinesecondarytospondylolisthesis(grades3and4)oftheL5-S1vertebrae,degenerativespondylolisthesiswithobjectiveevidenceofneurologicalimpairment,fracture,dislocation,scoliosis,kyphosis,spinaltumor,andfailedpreviousfusion(pseudoarthrosis).Thesafetyandeffectivenessofthesedevicesforanyotherconditionsareunknown.Radius®implantcomponentshavenotbeentestedforheatingormigrationinMRenvironment.

Removal of ImplantsTheseimplantsaretemporaryinternalfixationdevicesdesignedtostabilizetheoperativesiteduringthenormalhealingprocess.Afterhealingoccurs,thesedevicesservenofunctionalpurposeandcanberemoved.Removalmayalsoberecommendedinothercases,suchas:• Corrosionwithapainfulreaction• Migrationoftheimplant,withsubsequentpainand/orneurological,articularorsofttissuelesions• Painorabnormalsensationsduetothepresenceoftheimplants• Infectionorinflammatoryreactions• Reductioninbonedensityduetothedifferentdistributionofmechanicalandphysiologicalstressesandstrains• FailureormobilizationoftheimplantStandardancillariesprovidedbyStrykerSpinecanbeusedtoremovetheimplants.Anydecisionbyaphysiciantoremovetheinternalfixationdevicemusttakeintoconsiderationsuchfactorsastherisktothepatientoftheadditionalsurgicalprocedureaswellasthedifficultyofremoval.Removalofanunloosenedspinalscrewmayrequiretheuseofspecialinstrumentstodisrupttheinterfaceattheimplantsurface.Thistechniquemayrequirepracticeinthelaboratorybeforebeingattemptedclinically.Implantremovalmustbefollowedbyadequatepostoperativemanagementtoavoidfractureorre-fracture.Removaloftheimplantafterfracturehealingishighlyrecommended.Metallicimplantscanloosen,bend,fracture,corrode,migrate,causepainorstressshieldbone.

Information for PatientsThesurgeonmustdiscussallphysicalandpsychologicallimitationsinherenttotheuseofthedevicewiththepatient.Thisincludestherehabilitationregimen,physicaltherapy,andwearinganappropriateorthosisasprescribedbythephysician.Particulardiscussionshouldbedirectedtotheissuesofprematureweightbearing,activitylevels,andthenecessityforperiodicmedicalfollow-up.Thepatientmustbewarnedofthesurgicalrisksandmadeawareofpossibleadverseeffects.Thepatientmustbewarnedthatthedevicecannotanddoesnotreplicatetheflexibility,strength,reliabilityordurabilityofnormalhealthybone,thattheimplantcanbreakorbecomedamagedasaresultofstrenuousactivityortrauma,andthatthedevicemayneedtobereplacedinthefuture.Ifthepatientisinvolvedinanoccupationoractivitywhichappliesinordinatestressupontheimplant(e.g.,substantialwalking,running,lifting,ormusclestrain)he/sheshouldbewarnedthatresultantforcescancausefailureofthedevice.Patientswhosmokehavebeenshowntohaveanincreasedincidenceofnon-unions.Suchpatientsshouldbeadvisedofthisfactandwarnedofthepotentialconsequences.Fordiseasedpatientswithdegenerativedisease,theprogressionofdegenerativediseasemaybesoadvancedatthetimeofimplantationthatitmaysubstantiallydecreasetheexpectedusefullifeoftheappliance.Insuchcases,orthopaedicdevicesmaybeconsideredonlyasadelayingtechniqueortoprovidetemporaryrelief.

REUSENeverreuseorreimplantspinalsurgicalimplants.Thesecouldbecomecontaminatedresultingininfection.Inaddition,eventhoughthedeviceappearsundamaged,itmayhavesmalldefectswhichcouldcompromisestructuralintegrityreducingitsservicelifeand/orleadingtopatientinjury.Itisrecommendedtoverifythattheinstrumentsareingoodconditionandoperatingorderpriortouseduringsurgery.

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Asurgeonmustalwaysrelyonhisorherownprofessionalclinicaljudgmentwhendecidingwhethertouseaparticularproductwhentreatingaparticularpatient.Strykerdoesnotdispensemedicaladviceandrecommendsthatsurgeonsbetrainedintheuseofanyparticularproductbeforeusingitinsurgery.

TheinformationpresentedisintendedtodemonstratethebreadthofStrykerproductofferings.Asurgeonmustalwaysrefertothepackageinsert,productlabeland/orinstructionsforusebeforeusinganyStrykerproduct.Productsmaynotbeavailableinallmarketsbecauseproductavailabilityissubjecttotheregulatoryand/ormedicalpracticesinindividualmarkets.PleasecontactyourStrykerrepresentativeifyouhavequestionsabouttheavailabilityofStrykerproductsinyourarea.

StrykerCorporationoritsdivisionsorothercorporateaffiliatedentitiesown,useorhaveappliedforthefollowingtrademarksorservicemarks:Mantis®,Radius®,Stryker®,Xia®.Allothertrademarksaretrademarksoftheirrespectiveownersorholders.

LiteratureNumber:TLRADST08062SCGS07/10

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