Rationale and Surgical Technique for PCL and Multiple Knee Ligament Reconstruction

Featuring the Fanelli™ PCL/ACL System, Bio-Core™ Interference Screw, Poly Suture Button,

Fanelli™ Magellan Suture Retriever and Graft Tensioning Boot

Gregory C. Fanelli, M.D.

• FacilitatesPCLandACLreconstructiontechniques

Fanelli™ System Instruments

Graft Tensioning Boot• Selfretainingtensioner

eliminatesmanualtensioning

• Allowssurgeontousebothhandsfortibialfixation

• Tensiongraftsupto20lbs

Double Bundle Aimers• Sizespecificaimers

fordoublebundletunneldiameters

• AllowsvisualizationoftunnelplacementindoublebundlePCLandACLprocedurestoprovideadequatebonebridge

TheFanelli™ PCL/ACL Guide

facilitatesaccurateand

reproducibletunnelplacementfor

PCLandACLReconstructions.

Fanelli™ Magellan Suture Retriever• Facilitatessuture

retrievalduringPCLandACLreconstruction

• Promotesreproduciblegraftpassage

OverviewThismanualcontainsthesurgicaltechniqueforthetranstibialtunnelposteriorcruciateligament(PCL)reconstruction,combinedanteriorcruciateligament(ACL)andposteriorcruciateligamentreconstructionusingtheArthrotek®Fanelli™PCL/ACLSystem,andseveralmethodsofmedialandlateralsidereconstructions.Thereferencesectioncontainsalistoftextbooks,andscientificarticlesonthesesubjects,andthereaderisreferredtotheseresourcesforamoreindepthreviewofthesubjectmaterial.

Patient PositioningThepatientisplacedontheoperatingroomtableinthesupineposition,andaftersatisfactoryinductionofanesthesia,theoperativeandnonoperativelowerextremitiesarecarefullyexamined.Atourniquetisappliedtotheupperthighoftheoperativeextremity,andthatextremityispreppedanddrapedinasterilefashion.

Whenallografttissueisused,itispreparedpriortobringingthepatientintotheoperatingroom.Autografttissueis

harvestedpriortobeginningthearthroscopicportionoftheprocedure.

Thearthroscopicinstrumentsareinsertedwiththeinflowthroughthesuperolateralpatellarportal.Instrumentationandvisualizationisachievedthroughinferomedialandinferolateralpatellarportals,andcanbeinterchangedasnecessary.Additionalportalsareestablishedasnecessary.Explorationofthejointconsistsofevaluationofthepatellofemoraljoint,themedialandlateralcompartments,medialandlateralmenisci,andtheintercondylarnotch.

Whenthereisaposteriorcruciateligamenttear,thetearofthePCLisidentifiedandtheintactanteriorcruciateligamentisconfirmed.Theresidualstumpoftheposteriorcruciateligamentisdebridedwiththesynovialshaverandhandtoolsasnecessary.InthecaseofacombinedACL/PCLinjury,theresidualstumpsofboththeanteriorandposteriorcruciateligamentsaredebrided.InpatientswithcombinedACL/PCLinjuries,thenotchplastyfortheACLportionoftheprocedureisperformedatthistime.

Rationale and Surgical Technique for PCL and Multiple Knee Ligament Reconstruction

Poly Suture Button

• SolidfixationforeitherprimaryorauxiliaryfixationinACLorPCLreconstruction

• DistalfixationallowscircumferentialhealingoftheACLand/orPCLgrafttothetunnelwall

Bio-Core™ Interference Screw• Resorbableinterference

screwmadeofLactoSorb®L15resorbablecopolymer

• Abilitytobefilledwithautograftorallograftbone

ThisbrochureispresentedtodemonstratethesurgicaltechniqueutilizedbyGregoryFanelli,M.D.Arthrotek,asthemanufacturerofthisdevice,doesnotpracticemedicineanddoesnotrecommendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordeterminingandutilizingtheappropriatetechniquesforsuchprocedureforeachindividualpatient.Arthrotekisnotresponsibleforselectionoftheappropriatesurgicaltechniquetobeutilizedforanindividualpatient.

Rehabilitationactivitiesvarydependingontheindividualpatientandphysician’srecommendations.

TheFanelli™PCL/ACLSystemwasdevelopedinconjunctionwithGregoryC.Fanelli,M.D.,Danville,Pennsylvania.

Bio-Core™andFanelli™aretrademarksofArthrotek,Inc.

LactoSorb®isatrademarkofBiometManufacturingCorp.

Surgical Technique

Figure 1

Figure 3

Initial IncisionAnextracapsularextraarticularposteromedialsafetyincisionismadebycreatinganincisionapproximately1.5to2cmlongstartingattheposteromedialborderofthetibiaapproximatelyoneinchbelowthelevelofthejointlineandextendingdistally(Figure1).Dissectioniscarrieddowntothecruralfascia,whichisincisedlongitudinally.Careistakentoprotecttheneurovascularstructures.Anintervalisdevelopedbetweenthemedialheadofthegastrocnemiusmuscleposterior,andthecapsuleofthekneejointanterior.Thesurgeon’sglovedfingerisabletopositiontheneurovascularstructuresposteriortothefingerandthecapsuleanteriortothefinger(Figure2).Thisissothatthesurgeoncanmonitortoolssuchastheover-the-topPCLtools,andtheFanelli™PCL/ACLdrillguideasitispositionedintheposterioraspectoftheknee.Thisalsoallowsforaccurateplacementoftheguidewirebothinamediallateral,andaproximaldistaldirection.ThePCLandACLreconstructionsareperformedwiththekneeinapproximately70˚–90˚ofkneeflexion.

Elevating the CapsuleThecurvedover-the-topPCLinstrumentsareusedtosequentiallylyseadhesionsintheposterioraspectoftheknee,andelevatethecapsulefromthetibialridgeposterior.ThiswillallowaccurateplacementoftheFanelli™PCL/ACLguide,andcorrectplacementofthetibialtunnel(Figure3).

Figure 2

Positioning of the GuideThearmoftheFanelli™PCL/ACLguideisinsertedthroughtheinferiormedialpatellarportal.ThetipoftheguideispositionedattheinferiorlateralaspectofthePCLanatomicinsertionsite.ThisisbelowthetibialridgeposteriorandinthelateralaspectofthePCLanatomicinsertionsite.Thebulletportionoftheguidecontactstheanteromedialsurfaceoftheproximaltibiaatapointmidwaybetweentheposteromedialborderofthetibia,andthetibialcrestanteriorapproximately1cmbelowthetibialtubercle(Figure4).Thiswillprovideanangleofgraftorientationsuchthatthegraftwillturntwoverysmooth45˚anglesontheposterioraspectofthetibiaandwillnothaveanacute90˚angleturnwhichmaycausepressurenecrosisofthegraft(Figure5).

Thetipoftheguide,intheposterioraspectofthetibia,isconfirmedwiththesurgeon’sfingerthroughtheextracapsularextraarticularposteromedialsafetyincision.IntraoperativeAPandlateralX-raymayalsobeused.TheFanelli™PCL/ACLguidemaybeadjustedsothattheguidewireshootstothetiportheelbowoftheguideasthesurgeonprefers.WhentheFanelli™PCL/ACLguideispositionedinthedesiredarea,abluntspade-tippedguidewire(909634)isdrilledfromanteriortoposterior.Thearthroscope,intheposteriormedialportal,visualizesthetipoftheguidewire.Thesurgeon’sfingerconfirmsthepositionoftheguidewirethroughtheposteriormedialsafetyincision.Thisisadoublesafetycheck.

Figure 4

Figure 5

Surgical Technique

Figure 7

Figure 6

Drilling the Tibial TunnelTheappropriatelysizedstandardcannulatedreamerisusedtocreatethetibialtunnel.ThecurvedPCLclosedcuretteispositionedtocupthetipoftheguidewire.Thearthroscope,positionedintheposteriormedialportal,visualizestheguidewirebeingcupped,whichprotectstheneurovascularstructures(Figure6).Thesurgeon’sfingerthroughtheextracapsularextraarticularposteromedialincisionismonitoringthepositionoftheguidewire.Whenthedrillisengagedinbone,theguidewireisreversed,bluntendpointingposterior,foradditionalpatientsafety.

Thedrillisadvanceduntilitcomestotheposteriorcortexofthetibia.Thechuckisdisengagedfromthedrill,andcompletionofthetibialtunnelisperformedbyhand(Figure7).Thisgivesanadditionalmarginofsafetyforcompletionofthetibialtunnel.ThetunneledgesarethenchamferedandraspedwiththeFanelli™PCL/ACLsystemrasp(Figure8).

Figure 8

Figure 9

Figure 10

Drilling the Femoral Tunnel Outside In: Single and Double Bundle PCL ReconstructionTheFanelli™PCL/ACLguideispositionedtocreatethefemoraltunnel.Thearmoftheguideisintroducedthroughtheinferomedialpatellarportalandispositionedsuchthattheguidewirewillexitthroughthecenterofthestumpoftheanteriorlateralbundleoftheposteriorcruciateligament(Figure9).

Thebluntspade-tippedguidewire(909634)isdrilledthroughtheguide,andjustasitbeginstoemergethroughthecenterofthestumpofthePCLanteriorlateralbundle,thedrillguideisdisengaged.Theaccuracyoftheplacementofthewireisconfirmedarthroscopicallywithprobingandvisualization.Caremustbetakentoensurethepatellofemoraljointhasnotbeenviolatedbyarthroscopicallyexaminingthepatellofemoraljointpriortodrilling.

Theappropriatelysizedstandardcannulatedreamerisusedtocreatethefemoraltunnel.Acuretteisusedtocapthetipoftheguidewiresothereisnoinadvertentadvancementoftheguidewire,whichmaydamagetheanteriorcruciateligamentorarticularsurface.Asthereamerisabouttopenetrateinteriorly,thereamerisdisengagedfromthedrillandthefinalreamingiscompletedbyhand(Figure10).Thisaddsanadditionalmarginofsafety.Thereamingdebrisisevacuatedwithasynovialshavertominimizefatpadinflammatoryresponsewithsubsequentriskofarthrofibrosis.Thetunneledgesarechamferedandrasped.

Surgical Technique

Figure 12

Figure 11

Drilling the Femoral Tunnel Outside In: Single and Double Bundle PCL Reconstruction (continued)WhenthedoublebundlePCLreconstructionisperformed,theFanelli™PCL/ACLguideispositionedtocreatethesecondfemoraltunnel.Thearmoftheguideisintroducedthroughtheinferiormedialpatellarportal,andispositionedsuchthattheguidewirewillexitthroughthecenterofthestumpoftheposteriormedialbundleoftheposteriorcruciateligament(Figure11).Thebluntspade-tippedguidewire(909634)isdrilledthroughtheguide,andjustasitbeginstoemergethroughthecenterofthestumpofthePCLposteriormedialbundle,thedrillguideisdisengaged.Theaccuracyoftheplacementofthewireisconfirmedarthroscopicallywithprobingandvisualization.Caremustbetakentoensurethattherewillbeanadequatebonebridge(approximately5mm)betweenthetwofemoraltunnelspriortodrilling.Thisisaccomplishedusingthecalibratedprobe,anddirectarthroscopicvisualization.

Theappropriatelysizedstandardcannulatedreamerisusedtocreatetheposteriormedialbundlefemoraltunnel.Acuretteisusedtocapthetipoftheguidewiresothereisnoinadvertentadvancementoftheguidewire,whichmaydamagetheanteriorcruciateligament,orarticularsurface.Asthereamerisabouttopenetrateinteriorly,thereamerisdisengagedfromthedrillandthefinalreamingiscompletedbyhand(Figure12).Thisaddsanadditionalmarginofsafety.Thereamingdebrisisevacuatedwithasynovialshavertominimizefatpadinflammatoryresponsewithsubsequentriskofarthrofibrosis.Thetunneledgesarechamferedandrasped.

Figure 13 Figure 14

Drilling the Femoral Tunnel Inside Out: Single and Double Bundle PCL ReconstructionThePCLsinglebundleordoublebundlefemoraltunnelscanbemadefrominsideoutusingtheFanelli™DoubleBundleAimers.Theappropriatelysizeddoublebundleaimerisinsertedthroughalowanteriorlateralpatellararthroscopicportal.ThedoublebundleaimerispositioneddirectlyonthefootprintofthefemoralanteriorlateralbundlePCLinsertionsite(Figure13).Theappropriatelysizedguidewireisdrilledthroughtheaimer,throughthebone,andoutasmallskinincision.Careistakentoinsurethereisnocompromiseofthearticularsurface.

Thedoublebundleaimerisremoved,andanacornreamerisusedtoendoscopicallydrillfrominsideouttheanteriorlateralbundlePCLfemoraltunnel(Figure14).Thetunneledgesarechamferedandrasped.Thereamingdebrisisevacuatedwithasynovialshavertominimizefatpadinflammatoryresponsewithsubsequentriskofarthrofibrosis.WhenthesurgeonchoosestoperformadoublebundledoublefemoraltunnelPCLreconstruction,thesameprocessisrepeatedfortheposteriormedialbundleofthePCL(Figures15and16).Caremustbetakentoensurethattherewillbeanadequatebonebridge(approximately5mm)betweenthetwofemoraltunnelspriortodrilling.Thisisaccomplishedusingthecalibratedprobe,anddirectarthroscopicvisualization.

Figure 16

Figure 15

Surgical Technique

Figure 18

Figure 17

Figure 20

Tunnel Preparation, Graft Passage, and PCL Femoral FixationAFanelli™Magellansutureretriever(909808)isintroducedthroughthetibialtunnelintothejoint(Figure17),andmayberetrievedthroughthefemoraltunnel(Figure18).ThetractionsuturesofthegraftmaterialareattachedtotheloopoftheMagellansutureretriever,andthegraftispulledintoposition.ThegraftmaterialissecuredonthefemoralsideusingtheArthrotek®Bio-Core™InterferenceScrewforprimaryapertureopeningfixation,andanArthrotek®PolySutureButtonforbackupfixation.

PCL Graft Tensioning and Tibial FixationTensionisplacedonthePCLgraftdistallyusingtheArthrotek®GraftTensioningBoot,andthetensionissettorestoretheanatomictibialstepoff.Thekneeiscycledthroughafullrangeofmotion25timestoallowpre-tensioningandsettlingofthegraft.IndoublebundlePCLreconstructions,eachbundleisindividuallytensioned.Theprocessisrepeateduntilthereisnofurtherchangeinthetorquesettingonthegrafttensionerandtheanatomictibialstepoffisrestored.Thekneeisplacedin70˚offlexion,andfixationisachievedonthetibialsideofthePCLgraftwithanArthrotek®Bio-Core™InterferenceScrew,andbackupfixationwithabicorticalscrewandspikedligamentwasher(Figure20).

Figure 19

Figure 22

Figure 21

ACL ReconstructionWiththekneeinapproximately70˚–90˚offlexion,theACLtunnelsarecreatedusingtheFanelli™PCL/ACLguide.ThearmoftheFanelli™PCL/ACLguideentersthekneejointthroughtheinferiormedialpatellarportal(Figure21).Thebulletofthedrillguidecontactstheanteriormedialproximaltibiaexternallyatapointapproximately1cmproximaltothetibialtuberclemidwaybetweentheposteriormedialborderofthetibia,andthetibialcrestanteriorly.TheguidewireisdrilledthroughtheguidetoemergethroughthecenterofthestumpoftheACLtibialfootprint.Astandardcannulatedreamerisusedtocreatethetibialtunnel(Figure22).Reamingdebrisisevacuated,andthetunneledgesarechamferedandrasped.

Surgical Technique

Figure 24

ACL Reconstruction (continued)Withthekneeinapproximately90˚offlexion,anoverthetopFemoralAimerisintroducedthroughthetibialtunnel,andusedtopositionaguidewireonthemedialwallofthelateralfemoralcondyle(Figure23).ThefemoraltunneliscreatedtoapproximatetheACLanatomicinsertionsite,andtheoffsetofthesizespecificFemoralAimerwillleavea1–2mmposteriorcorticalwallsointerferencefixationcanbeused(Figure24).TheACLgraftispositioned,andfixationachievedonthefemoralsideusinganArthrotek®Bio-Core™InterferenceScrew,andbackupfixationwithanArthrotek®PolySutureButton.

TheACLgraftistensionedonthetibialsideusingtheArthrotek®GraftTensioningBoot(Figure25).TractionisplacedontheACLgraftsutures,andtensionisset.Thekneeisthencycledthrough25fullflexionandextensioncyclestoallowsettlingofthegraft.Theprocessisrepeateduntilthereisnofurtherchangeinthetorquesettingonthegrafttensioner.Thekneeisplacedin70˚offlexion,andfixationisachievedonthetibialsideoftheACLgraftwithanArthrotek®Bio-Core™InterferenceScrew,andbackupfixationwithanArthrotek®PolySutureButton.ThefinalACLandPCLtunnelpositionsaredemonstratedinFigures26and27.

Figure 23

Figure 25

Figure 26

Figure 27

Surgical Technique

Figure 28

Lateral Posterolateral ReconstructionPosterolateralreconstructionwiththefreegraftfigureofeighttechniqueutilizessemitendinosusautograftorallograft,Achillestendonallograft,orothersofttissueallograftmaterial(Figure28).AcurvilinearincisionismadeinthelateralaspectofthekneeextendingfromthelateralfemoralepicondyletotheintervalbetweenGerdy’stubercleandthefibularhead.Theperonealnerveisdissectedfree,andprotectedthroughouttheprocedure.Thefibularheadisexposedandatunneliscreatedinananteriortoposteriordirectionattheareaofmaximalfibulardiameter.Thetunneliscreatedbypassingaguidepinfollowedbyacannulateddrillusually7mmindiameter.Thefreetendongraftispassedthroughthefibularheaddrillhole.Anincisionisthenmadeintheiliotibialbandinlinewiththefibersdirectlyoverlyingthelateralfemoralepicondyle.

Onesurgicaltechniqueforposterolateralreconstructionisthefreegraftfigureofeighttechniqueutilizingsemitendinosusautograftorallograft,Achillestendonallograft,orothersofttissueallograftmaterial(Figure28).Thisprocedurerequiresanintactproximaltibiofibularjoint.Thistechniquecombinedwithcapsularrepairand/orposterolateralcapsularshiftprocedures,mimicsthefunctionofthepopliteofibularligamentandlateralcollateralligament,tightenstheposterolateralcapsule,andprovidesapostofstrongallografttissuetoreinforcetheposterolateralcorner.Whenthereisadisruptedproximaltibiofibularjoint,orhyperextensionexternalrotationrecurvatumdeformity,atwo-tailed(fibularhead,proximaltibia)posteriorlateralreconstructionmayberequired(Figure29).

Figure 29

Thegraftmaterialispassedmedialtotheiliotibialband,andthelimbsofthegraftarecrossedtoformafigureofeight.Adrillholeismadeapproximately1cmanteriortothefibularcollateralligamentandpopliteustendonfemoralinsertion.Alongitudinalincisionismadeinthelateralcapsulejustposteriortothefibularcollateralligament.Thegraftmaterialispassedmedialtotheiliotibialbandandsecuredtothelateralfemoralepicondylarregionwithascrewandspikedligamentwasherattheabovementionedpoint.Theposterolateralcapsulethathadbeenpreviouslyincisedisthenshiftedandsewnintothestrutoffigureofeightgrafttissuematerialtoeliminateposterolateralcapsularredundancy.Theanteriorandposteriorlimbsofthefigureofeightgraftmaterialaresewntoeachothertoreinforceandtightentheconstruct.Thefinalgrafttensioningpositionisapproximately30˚–40˚ofkneeflexion.Theiliotibialbandincisionisclosed.

Surgical Technique

Figure 31

Figure 30

Medial Posteromedial ReconstructionWhensuperficialMCLreconstructionisindicated,thisisperformedusingallograftorautografttissue(Figure31).Thisgraftmaterialisattachedattheanatomicinsertionsitesofthesuperficialmedialcollateralligamentonthefemurandtibiausingascrewandspikedligamentwasher,orsutureanchors.Theposteromedialcapsularadvancementisperformed,andsewnintothenewlyreconstructedMCL.Thefinalgrafttensioningpositionisapproximately30˚–40˚ofkneeflexion.

Posteromedialandmedialreconstructionsareperformedthroughamedialincision.Careistakentomaintainadequateskinbridgesbetweenincisions,andtoprotecttheneurovascularstructures.Thesuperficialmedialcollateralligamentisexposed,andalongitudinalincisionismadejustposteriortotheposteriorborderofthesuperficialMCL(Figure30).

Careistakentoprotectthemedialmeniscusduringthecapsularincision.Theintervalbetweentheposteromedialcapsuleandmedialmeniscusisdeveloped.Theposteromedialcapsuleisshiftedanterosuperiorly.Themedialmeniscusisrepairedtothenewcapsularposition,andtheshiftedcapsuleissewnintothemedialcollateralligament.

Overview of Graft Tensioning and FixationThePCLisreconstructedfirstfollowedbytheACLfollowedbytheposterolateralcomplex,andmedialligamentcomplex.TensionisplacedonthePCLgraftdistallyusingtheArthrotek®GraftTensioningBoot.Thisrestorestheanatomictibialstepoff.Thekneeiscycledthroughafullrangeofmotion25timestoallowpretensioningandsettlingofthegraft.Thekneeisplacedin70˚offlexion,andfixationisachievedonthetibialsideofthePCLgraftwithanArthrotek®Bio-Core™InterferenceScrew,andscrewandspikedligamentwasher.TheArthrotek®GraftTensioningBootisappliedtotheACLgraft.

Thekneeisplacedin70˚offlexion,andfinalfixationisachievedoftheACLgraftwithaArthrotek®Bio-Core™InterferenceScrew,andArthrotek®PolySutureButtonback-upfixationonthefemoralandtibialsides.TensioningtheACLgraftat70˚ofkneeflexionenabledustomaintaintheneutralpositionofthekneebymonitoringthetibialstepoffatthetimeoffinalgraftfixation.Thekneeisplacedin30˚offlexion,slightvalgusforceappliedtotheknee,andfinaltensioningandfixationoftheposterolateralcornerisachieved.TheMCLreconstructionistensionedwiththekneein30˚offlexion.Fullrangeofmotionisconfirmedontheoperatingtabletoassurethekneeisnot“captured”bythereconstruction.

Additional Technical IdeasTheposteromedialsafetyincisionprotectstheneurovascularstructuresandconfirmsaccuratetibialtunnelplacement.Itisimportanttobeawareofthetwotibialtunneldirections,andtohaveanadequatebonebridgebetweenthePCLandACLtibialtunnels.Thiswillreducethepossibilityoffracture.Wehavefounditusefultouseprimaryandback-upfixation.PrimaryfixationiswithArthrotek®Bio-Core™InterferenceScrews,andback-upfixationisperformedwithascrewandspikedligamentwasher,anArthrotek®PolySutureButton.

Securefixationiscriticaltothesuccessofthissurgicalprocedure.Restorationofthenormaltibialstep-offat70˚offlexionhasprovidedthemostreproduciblemethodofestablishingtheneutralpointofthetibia-femoralrelationshipinourexperience.Fullrangeofmotionisconfirmedontheoperatingtabletoassurethekneeisnot“captured”bythereconstruction.

TheFanelliSportsInjuryClinicresultsforourPCLandmultipleligamentkneereconstructionsaredetailedinthereferenceslistedinthistechniquemanual.Thereaderisreferredtotheseresources.

References

PCL and Multiple Knee Ligament Injury Text Books by Gregory C. Fanelli, M.D.Posterior Cruciate Ligament Injuries: A Practical Guide To Management. Editor:GregoryC.Fanelli,M.D.,Springer-Verlag,NewYork,2001.

The Multiple Ligament Injured Knee. A Practical Guide to Management. Editor:GregoryC.Fanelli,M.D.,Springer-Verlag,NewYork,2004.

PCL and Multiple Knee Ligament Injury Related Peer Reviewed Articles by Gregory C. Fanelli, M.D.GregoryC.Fanelli,M.D.,“PosteriorCruciateLigamentInjuriesInTraumaPatients.”Arthroscopy9(3)pp.291–294,1993.

GregoryC.Fanelli,M.D.,BradleyGiannotti,M.D.,CraigEdson,P.T.:“CurrentConceptsReview.ThePosteriorCruciateLigament:ArthroscopicEvaluationAndTreatment.”ArthroscopyVol.10,No.6.pp.673–688,December,1994.

GregoryC.Fanelli,M.D.,CraigJ.Edson,P.T./A.T.C.:“PosteriorCruciateLigamentInjuriesInTraumaPatients:PartII.”ArthroscopyVol.11,No.5.pp.526–529,1995.

GregoryC.Fanelli,M.D.,BradleyGiannotti,M.D.,CraigJ.Edson,M.S.,P.T.,A.T.C.:ArthroscopicallyAssistedCombinedACL/PCLReconstruction.Arthroscopy,Vol.12,No.1.,pp.5–14,1996.

GregoryC.Fanelli,M.D.,BradleyGiannotti,M.D.,CraigJ.Edson,M.S.,P.T.,A.T.C.:“ArthroscopicallyAssistedPCL/PosteriorLateralComplexReconstruction.”Arthroscopy,Vol.12,No.5,1996.

RaymondM.Bleday,M.D.,GregoryC.Fanelli,M.D.,BradleyF.Giannotti,M.D.,CraigJ.Edson,M.H.S.,P.T.,A.T.C.,ThomasABarrett,M.D.:“InstrumentedMeasurementofthePosterolateralCorner.”Arthroscopy,Vol.14,No.5:489–494,1998.

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GregoryC.Fanelli,M.D.:“ArthroscopicPosteriorCruciateLigamentReconstruction:TranstibialTunnelTechnique.SurgicalTechniqueand2–10YearResults.”Arthroscopy,18(9):44–49,(DecemberSupplement2),2002.

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GregoryC.Fanelli,M.D.,CraigJEdson,M.S.,P.T./A.T.C.:“CombinedPosteriorCruciateLigament–PosterolateralReconstructionwithAchillesTendonAllograftandBicepsFemorisTendonTenodesis:2–10yearFollow-up.”Arthroscopy,20(4):339–345,2004.

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BergfeldJA,CooperDE,FanelliGC,HarnerCD:“RoundTableDiscussion.ReconstructingthePCL:TipsandTechniques.”Orthopaedics Today,24(12):1,16–21,2004.

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GregoryC.Fanelli,M.D.:“SurgicalTreatmentofLateralPosterolateralInstabilityoftheKneeUsingBicepsFemorisTendonProcedures.”Sports Medicine and Arthroscopy Review,February,14(1),2006.

FanelliGC,HarrisJD:“SurgicalTreatmentofAcuteMedialCollateralLigamentandPosteromedialCornerInjuriesoftheKnee.Sports Medicine and Arthroscopy Review,May,14(2),2006.

FanelliGC,HarrisJD.:“LateMCL(MedialCollateralLigament)Reconstruction.”Techniques In Knee Surgery,(InPress),2006.

Package Inserts

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please use the contact information provided herein.

Arthrotek,Inc. 01-50-1058AWhollyOwnedSubsidiaryofBiomet,Inc. Date:07/0456EastBellDriveP.O.Box587Warsaw,Indiana46581USA

RESORBABLE INTERFERENCE SCREWATTENTION OPERATING SURGEON

DESCRIPTIONArthrotek® Resorbable Interference Screw is a resorbable interference fixation screw. ThedeviceismadeofLactoSorb®,aresorbablecopolymer,whichisapolyesterderivativeoflacticacidandglycolicacid.Polylactic/polyglycolicacidcopolymerdegradesandresorbs in vivobyhydrolysistolacticandglycolicacidsthatarethenmetabolizedbythebody.

INDICATIONSIndicationsforuse:IndicationsfortheResorbableInterferenceScrewincludeuseinsofttissuereattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specificindicationsincludethefollowing:

Shoulder:Bankartrepair,SLAPlesionrepair,acromio-clavicularseparation,rotatorcuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis,deltoidrepair.Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateralligamentreconstruction.Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction,halluxvalgusreconstruction,mid-andforefootreconstruction.Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction,bicepstendonreconstruction.Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateralcollateral ligament (LCL) repair, posterior oblique ligament repair, joint capsuleclosure,iliotibialbandtenodesisreconstruction,patellarligament/tendonrepair,andvastusmedialisobliquus(VMO)muscleadvancement.

Inadditiontotheaboveindications,7.0mm,8.0mm,9.0mm,10.0mm,11.0mm,and12.0mmscrewsareindicatedforthefollowinguses: 1. Toprovideinterferencefixationofpatellarbone-tendon–bonegraftsinanterior cruciateligament(ACL)reconstruction. 2. Toprovideinterferencefixationduringfemoraland/ortibialfixationinanterior cruciateligamentreconstructionusingasofttissuegraft(semitendinosus,gracilis). 3. Toprovideinterferencefixationduringposteriorcruciateligament(PCL) reconstruction.

CONTRAINDICATIONS 1. Activeinfection. 2. Patientswithmentalorneurologicconditionswhoareunwillingorincapableof followingpostoperativecareinstructions. 3. Patientconditionsincluding:bloodsupplylimitations,insufficientquantityorquality ofboneforattachmentorlatentinfections. 4. Pathologicsofttissueconditions,whichwouldpreventsecurefixations.

WARNINGSArthrotekinternalfixationdevicesprovidethesurgeonwithameanstoaidinthemanagementofsofttissuetobonereattachmentprocedures.Whilethesedevicesaregenerallysuccessfulin attaining these goals, they cannot be expected to replace normal healthy soft tissueor withstand the stress placed upon the device by full or partial weight bearing or loadbearing, particularly in the presence of incomplete healing. Therefore, it is important thatimmobilization (use of external support, sling, etc.) of the treatment site be maintaineduntil healing has occurred. Surgical implants are subject to repeated stresses in use, whichcan result in fracture or damage to the implant. Factors such as the patient’s activity levelandadherencetoweightbearingorloadbearinginstructionshaveanaffectontheservicelifeoftheimplant.Thesurgeonmustbethoroughlyknowledgeablenotonlyinthemedicalandsurgicalaspectsoftheimplant,butalsomustbeawareofthemechanicalandpolymericaspectsofthesurgicalimplants.

1. Correctselectionoftheimplantisextremelyimportant.Thepotentialforsuccess insofttissuetobonefixationisincreasedbytheselectionofthepropertype ofimplant.Whileproperselectioncanhelpminimizerisks,thedeviceisnotdesigned towithstandtheunsupportedstressoffullweightbearing,loadbearingorexcessive activity. 2. Theimplantscanloosenorbedamagedwhensubjectedtoincreasedloading associatedwithinadequatehealing.Ifhealingisdelayed,ordoesnotoccur,the implantortheproceduremayfail.Loadsproducedbyweightbearingandactivity levelsmaydictatethelongevityoftheimplant. 3. Inadequatefixationatthetimeofsurgerycanincreasetheriskoflooseningand migrationofthedeviceortissuesupportedbythedevice.Sufficientbonequantity andqualityareimportanttoadequatefixationandsuccessoftheprocedure.Bone qualitymustbeassessedatthetimeofsurgery.Adequatefixationindiseasedbone maybemoredifficult.Patientswithpoorqualitybone,suchasosteoporoticbone,are atgreaterriskofdevicelooseningandprocedurefailure.

4. Careistobetakentoassureadequatesofttissuefixationatthetimeofsurgery. Failuretoachieveadequatefixationthroughimproperpositioningorplacementof thedevicecancontributetoasubsequentundesirableresult. 5. Theuseofappropriateimmobilizationandpostoperativemanagementisindicated aspartofthetreatmentuntilhealinghasoccurred. 6. Correcthandlingofimplantsisextremelyimportant.Donotmodifyimplants.Do notnotchorbendimplants.Notchesorscratchesputintheimplantduringthe courseofsurgerymaycontributetobreakage.Intraoperativefractureofscrewscan occurifexcessiveforce(torque)isappliedwhileseatingbonescrews. 7. DonotheatLactoSorb®InterferenceScrewsbyanymeanspriortoimplantation. 8. DONOTUSEifthereislossofsterilityofthedevice.DiscardandDONOTUSEopened ordamageddevices,anduseonlydevicesthatarepackagedinunopenedand undamagedcontainers. 9. DONOTUSEwhereapermanentimplantisindicated. 10. DONOTUSEwithotherresorbableimplantmaterials. 11. Adequatelyinstructthepatient.Postoperativecareisimportant.Thepatient’sability

andwillingnesstofollowinstructionsisoneofthemostimportantaspectsofsuccessfulsofttissuemanagement.Patientsaffectedwithsenility,mentalillness,alcoholism,anddrugabusemaybeatahigherriskofdeviceorprocedurefailure.Thesepatientsmayignoreinstructionsandactivityrestrictions.Thepatientistobeinstructedintheuseofexternalsupportsthatareintendedtoimmobilizetherepairsiteandlimitweightbearingorloadbearing.Thepatientistobemadefullyawareandwarnedthatthedevicedoesnotreplacenormalhealthytissue,andthatthedevicecanbreak,bendorbedamagedasaresultofstress,activity,loadbearing,orweightbearing.Thepatientistobemadeawareandwarnedofgeneralsurgicalrisks,possibleadverseeffects,andtofollowtheinstructionsofthetreatingphysician.Thepatientistobeadvisedoftheneedforregularpostoperativefollow-upexaminationaslongasthedeviceremainsimplanted.

PRECAUTIONSInstruments are available to aid in the accurate implantation of internal fixation devices.Intraoperative fracture or breaking of instruments has been reported. Surgical instrumentsaresubjecttowearwithnormalusage. Instruments,whichhaveexperiencedextensiveuseorexcessive force,aresusceptible to fracture.Surgical instrumentsshouldonlybeused fortheir intended purpose. Arthrotek recommends that all instruments be regularly inspectedforwearanddisfigurement.

POSSIBLE ADVERSE EFFECTS 1. Infectioncanleadtofailureoftheprocedure. 2. Neurovascularinjuriescanoccurduetosurgicaltrauma. 3. Bending,fracture,loosening,rubbing,andmigrationoftheimplantmayoccurasa resultofexcessiveactivity,trauma,orloadbearing. 4. Implantationofforeignmaterialscanresultinaninflammatoryresponseorallergic reaction. 5. Inadequatehealingwhichmayleadtobreakageoftheimplantorfailureofthegraft material. 6. Pain,discomfort,orabnormalsensationduetothepresenceofthedevice. 7. Necrosisoftheboneortissue.

STERILITYArthrotekresorbableimplantsaresterilizedbyexposuretoEthyleneOxide(ETO)Gas.Donotresterilize.Donotusepastexpirationdate.

STOREATORBELOWROOMTEMPERATURE.DONOTEXPOSEPRODUCTTOTEMPERATURESGREATERTHAN120°FOR49°C.

Caution:FederalLaw(USA)restrictsthisdevicetosale,distribution,orusebyorontheorderofaphysician.

Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc.,P.O.Box587,Warsaw,IN46581USA,Fax:574-372-1683.

Manufacturer: AuthorizedRepresentative:BiometManufacturingCorp. BiometU.K.,LtdAirportIndustrialPark WatertonIndustrialEstatesP.O.Box587 Bridgend,SouthWalesWarsaw,IN46581-0587 CF313XA,U.K.

СЄ0086

Arthrotek,Inc.01-50-1018AWhollyOwnedSubsidiaryofBiomet,Inc. Date:09/05P.O.Box58756EastBellDriveWarsaw,Indiana46581USA

Arthrotek® Internal Fixation Devices Attention Operating Surgeon

DESCRIPTIONArthrotekmanufacturesavarietyofinternalfixationdevicesintendedtoaidinarthroscopicandorthopedicreconstructiveproceduresrequiringsofttissuefixation,duetoinjuryordegenerativedisease.Implantsusedforthisapplicationinclude:screws,washers,anchors,pins,andsuture.Specialtyimplantsareavailableforspecializedtreatments.

Materials:316LVMStainlessSteelTitaniumAlloyUltra-HighMolecularWeightPolyethylene(UHMWPE)Polyester

INDICATIONSTheMetalScrewAnchorandtheHarpoon®SutureAnchorareindicatedforuseinsofttissuereattachmentproceduresintheshoulder,wrist,elbow,andknee.Specificindicationsasfollows:

ShoulderIndications–Bankartrepair,SLAPlesionrepair,acromio-clavicularseparation,rotatorcuffrepair,capsulerepairorcapsulolabralreconstruction,bicepstenodesis,deltoidrepair.Wrist/HandIndications–Scapholunateligamentreconstruction,ulnar/radialcollateralligamentreconstruction.Ankle/FootIndications–Lateralstabilization,medialstabilization,Achillestendonrepair/reconstruction,halluxvalgusreconstruction,mid-andforefootreconstruction.ElbowIndications–Ulnarorradialcollateralligamentreconstruction,bicepstendonreconstruction.KneeIndications–Medialcollateralligamentrepair,lateralcollateralligamentrepair,posteriorobliqueligamentrepair,jointcapsuleclosure,iliotibialbandtenodesis,andpatellarligament/tendonrepair.

BoneMulch®Screwsareintendedforuseinfixationofsemitendinousand/orgraciletendongraftsinACLreconstruction,only.

InterferenceScrewsandSetScrewsareintendedforuseinfixationofpatellarbone-tendon-bonegraftsinACLreconstruction.

ScrewandWashersareindicatedforsofttissuefixationtobone,andbonetobonefixationinorthopedicproceduresspecificallyduringLigamentreconstruction.

Toggleanchors(ie.togglebuttonsandEZLoc™)areindicatedforuseforfixationoftendonsandligamentsduringorthopedicreconstructionproceduressuchasAnteriorCruciateLigament(ACL)Reconstruction.

Patientselectionfactorstobeconsideredinclude:1)needforsofttissuetobonefixation,2)abilityandwillingnessofthepatienttofollowpostoperativecareinstructionsuntilhealingiscomplete,and3)agoodnutritionalstateofthepatient.

CONTRAINDICATIONS 1. Infection. 2. Patientconditionsincludingbloodsupplylimitations,andinsufficientquantityor

qualityofboneorsofttissue. 3. Patientswithmentalorneurologicconditionswhoareunwillingorincapableof

followingpostoperativecareinstructions. 4. Foreignbodysensitivity.Wherematerialsensitivityissuspected,testingistobe

completedpriortoimplantationofthedevice.

WARNINGSArthrotek®internalfixationdevicesprovidethesurgeonwithameanstoaidinthemanagementofsofttissuetobonereattachmentprocedures.Whilethesedevicesaregenerallysuccessfulinattainingthesegoals,theycannotbeexpectedtoreplacenormalhealthyboneorwithstandthestressplaceduponthedevicebyfullorpartialweightbearingorloadbearing,particularlyinthepresenceofnonunion,delayedunion,orincompletehealing.Therefore,itisimportantthatimmobilization(useofexternalsupport,walkingaids,braces,etc.)ofthetreatmentsitebemaintaineduntilhealinghasoccurred.Surgicalimplantsaresubjecttorepeatedstressesinuse,whichcanresultinfractureordamagetotheimplant.Factorssuchasthepatient’sweight,activitylevel,andadherencetoweightbearingorloadbearinginstructionshaveaneffectontheservicelifeoftheimplant.Thesurgeonmustbethoroughlyknowledgeablenotonlyinthemedicalandsurgicalaspectsoftheimplant,butalsomustbeawareofthemechanicalandmetallurgicalaspectsofthesurgicalimplants.

1. Correctselectionoftheimplantisextremelyimportant.Thepotentialforsuccessinsofttissuetobonefixationisincreasedbytheselectionofthepropertypeofimplant.Whileproperselectioncanhelpminimizerisks,neitherthedevicenorgrafts,whenusedaredesignedtowithstandtheunsupportedstressoffullweightbearing,loadbearingorexcessiveactivity.

2. Theimplantscanloosenorbedamagedandthegraftcanfailwhensubjectedtoincreasedloadingassociatedwithnonunionordelayedunion.Ifhealingisdelayed,ordoesnotoccur,theimplantortheproceduremayfail.Loadsproducedbyweightbearing,andactivitylevelsmaydictatethelongevityoftheimplant.

3. Inadequatefixationatthetimeofsurgerycanincreasetheriskoflooseningandmigrationofthedeviceortissuesupportedbythedevice.Sufficientbonequantityandqualityareimportanttoadequatefixationandsuccessoftheprocedure.Bonequalitymustbeassessedatthetimeofsurgery.Adequatefixationindiseasedbonemaybemoredifficult.Patientswithpoorqualitybone,suchasosteoporoticbone,areatgreaterriskofdevicelooseningandprocedurefailure.

4. Implantmaterialsaresubjecttocorrosion.Implantingmetalsandalloyssubjectsthemtoconstantchangingenvironmentsofsalts,acids,andalkalisthatcancausecorrosion.Puttingdissimilarmetalsandalloysincontactwitheachothercanacceleratethecorrosionprocessthatmayenhancefractureofimplants.Everyeffortshouldbemadetousecompatiblemetalsandalloyswhenmarryingthemtoacommongoal,i.e.,screwsandplates.

5. Correcthandlingofimplantsisextremelyimportant.Donotmodifyimplants.Donotnotchorbendimplants.Notchesorscratchesputintheimplantduringthecourseofsurgerymaycontributetobreakage.Intraoperativefractureofscrewscanoccurifexcessiveforce(torque)isappliedwhileseatingbonescrews.

6. Donotuseexcessiveforcewheninsertingsutureanchors.Excessiveforce(longhardhammerblows)maycausefractureorbendingofthedevice.Whenencounteringhardcorticalbone,predrillwitha3/32or1/8inchdrillpriortoinsertingsutureanchors.

7. Adequatelyinstructthepatient.Postoperativecareisimportant.Thepatient’sabilityandwillingnesstofollowinstructionsisoneofthemostimportantaspectsofsuccessfulfracturemanagement.Patientseffectedwithsenility,mentalillness,alcoholism,anddrugabusemaybeatahigherriskofdeviceorprocedurefailure.Thesepatientsmayignoreinstructionsandactivityrestrictions.Thepatientistobeinstructedintheuseofexternalsupports,walkingaids,andbracesthatareintendedtoimmobilizethefracturesiteandlimitweightbearingorloadbearing.Thepatientistobemadefullyawareandwarnedthatthedevicedoesnotreplacenormalhealthybone,andthatthedevicecanbreak,bendorbedamagedasaresultofstress,activity,loadbearing,orweightbearing.Thepatientistobemadeawareandwarnedofgeneralsurgicalrisks,possibleadverseeffects,andtofollowtheinstructionsofthetreatingphysician.Thepatientistobeadvisedoftheneedforregularpostoperativefollow-upexaminationaslongasthedeviceremainsimplanted.

PRECAUTIONSDonotreuseimplants.Whileanimplantmayappearundamaged,previousstressmayhavecreatedimperfectionsthatwouldreducetheservicelifeoftheimplant.Donottreatwithimplantsthathavebeenevenmomentarilyplacedinadifferentpatient.

Instrumentsareavailabletoaidintheaccurateimplantationofinternalfixationdevices.Intraoperativefractureorbreakingofinstrumentshasbeenreported.Surgicalinstrumentsaresubjecttowearwithnormalusage.Instruments,whichhaveexperiencedextensiveuseorexcessiveforce,aresusceptibletofracture.Surgicalinstrumentsshouldonlybeusedfortheirintendedpurpose.Arthrotekrecommendsthatallinstrumentsberegularlyinspectedforwearanddisfigurement.

IfdevicecontainsMaxBraid™suture,refertomanufacturerpackageinsertforfurtherinformation.

POSSIBLE ADVERSE EFFECTS 1. Nonunionordelayedunion,whichmayleadtobreakageoftheimplant. 2. Bendingorfractureoftheimplant. 3. Looseningormigrationoftheimplant. 4. Metalsensitivity,orallergicreactiontoaforeignbody. 5. Pain,discomfort,orabnormalsensationduetothepresenceofthedevice. 6. Nervedamageduetosurgicaltrauma. 7. Necrosisofboneortissue. 8. Inadequatehealing. 9. Intraoperativeorpostoperativebonefractureand/orpostoperativepain.

STERILITYArthrotek®internalfixationimplantsaretypicallysuppliedsterileandaresterilizedbyexposuretoaminimumdoseof25kGyofgammaradiationorbyEthyleneOxideGas(ETO)ifdevicecontainsMaxBraid™PEsuture.Ifsuppliedsterile,donotresterilizetheimplant.

Ifnotsuppliedsterile,metallicinternalfixationdevicesmustbesterilizedpriortosurgicaluse.DonotsterilizeUHMWPEimplantsusingsteamautoclavingmethods.Donotuseimplantsafterexpirationdate.

Pre-VacuumSteam(HI-VAC)--wrappedorunwrappedTemperature 270°-275°F(132°-135°C)ExposureTime 5MinutesDryingTime 8Minutes

SinceArthrotekisnotfamiliarwithindividualhospitalhandlingmethods,cleaningmethodsandbioburden,Arthrotekcannotassumeresponsibilityforsterilityeventhoughtheguidelineisfollowed.

Caution:Federallaw(USA)restrictsthisdevicetosalebyorontheorderofaphysician.

AuthorizedRepresentative: BiometU.K.,Ltd. WatertonIndustrialEstates,

Bridgend,SouthWales CF313XA,U.K.СЄ0086

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please use the contact information provided herein.

Ordering Information

Fanelli™ PCL/ACL Guide

909800 Body909804 PCLBullet

Fanelli™ Magellan

909808

Calibrated Probe

909799

Tunnel Awl

909798

Curved Rasp

909791

Cupped Curette

909792

Cupped Curette (Over the Back)

909793

Open Curette

909794

Open Curette (Over the Back)

909795

PCL Capsule Rasp

909790

Hook Knife

909796

Graft Tensioning Boot

909525

Fanelli™ Double Bundle Aimer

909747 7mm909748 8mm 909749 9mm909750 10mm909751 11mm909752 12mm

Femoral Aimer

909627 7mm909628 8mm 909629 9mm909630 10mm909631 11mm909632 12mm

Bio-Core™ Interference Screw

905635 7x20mm 905636 7x25mm 905637 7x30mm 905638 8x20mm 905639 8x25mm 905640 8x30mm 905641 9x20mm 905642 9x25mm 905643 9x30mm 905644 10x20mm 905645 10x25mm 905646 10x30mm

Poly Suture Button

904215 15mm 904219 19mm

Resorbable No-Profile Screw

905401 6.5x25mm 905402 6.5x30mm 905403 6.5x35mm 905404 6.5x40mm 905405 6.5x45mm 905406 6.5x50mm 905407 6.5x55mm

Resorbable No-Profile Spiked Washer

905418 18mm

No-Profile Cancellous Screw

904530 6.5x30mm 904535 6.5x35mm 904540 6.5x40mm 904545 6.5x45mm 904550 6.5x50mm 904555 6.5x55mm 904560 6.5x60mm 904565 6.5x65mm 904570 6.5x70mm

No-Profile Cortical Screw (Self Tapping)

904630 6.5x30mm 904632 6.5x32mm 904634 6.5x34mm 904636 6.5x36mm 904638 6.5x38mm 904640 6.5x40mm 904642 6.5x42mm 904644 6.5x44mm 904646 6.5x46mm 904648 6.5x48mm 904650 6.5x50mm 904652 6.5x52mm 904654 6.5x54mm 904656 6.5x56mm 904658 6.5x58mm 904660 6.5x60mm

No-Profile Spiked Washer

904414 14mm 904418 18mm 904420 20mm

No-Profile Flat Washer

904428 18mm

Femoral Aimer Handle

909623

Femoral Aimer Replacement Ring Nut

909627-03

Cannulated Drill Bit

909911 7mm909913 8mm 909915 9mm909917 10mm909919 11mm909921 12mm

Graft Sizing Block

906820

Cannulated End Cutting Reamer

909617 7mm909618 8mm 909619 9mm909620 10mm909621 11mm909622 12mm

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501 • ©2006 Arthrotek, Inc. All Rights Reservedweb site: www.arthrotek.com • eMail: arthrotek@arthrotek.com

Form No. Y-BMT-979/071506/K

I N V E N T I N G T H E F U T U R E O F A R T H R O S C O P Y