ACL Reconstruction— Medial Portal

Surgical Protocol by Jefferey Michaelson, M.D.

with ZipLoop™ Technology For ACL Reconstruction

Features• Auniqueweaveinwhichasinglestrandofbraidedpolyethyleneiswoventhroughitselftwiceinoppositedirections

• ThisconstructallowsBiometSportsMedicinetoproduceinnovativeproductsthatcanvaryinlengthandcompression/tensionaddressingtheindividualneedsofeachpatient

• ProductsutilizingZipLoop™Technologyareresistanttoslippagewithouttyingknots1

Benefits• Maximizessofttissuegraft-to-tunnelinterface

• Oneimplantforvaryingtunnellengths—eliminatestheneedformultiplesizes

• ForuseinbothtranstibialandanteromedialportalACLreconstruction

• Tensionmaybeappliedfromfemoralsideaftertibialfixationhasbeenachieved

• Virtuallynoslippageaftercyclicloading1

• Simplesurgicaltechniquerequiresminimalinstrumentation

• Femoralfixationdevicedesignedtocapturethecorticalboneofthefemur

Features• Madefromacompositematerialwithaninnovativeblendof40%PLDLAand60%betaTri-CalciumPhosphatethatisdesignedforsoft-tissuefixation

• Uniquestar-shapeddrivemechanismthatlimitsstressanddistributestorqueevenlyonthescrewduringinsertion1

New… from Biomet Sports Medicine

Available in fully-threaded and round head design

Round Head Fully Threaded

9x25mm 9x30mm 9x35mm 10x30mm 10x35mm 11x30mm 11x35mm

Sizing

Theresultsreportedinanin-vivoanimalstudy2showedthat“incomparisonwithpurePLA,TCP-containingcom-positematerialshadfasterdegradationkinetics,causedlessinflammatoryreaction,andpromotedcontactosteo-genesis.1

TheComposiTCP™InterferenceScrewhasmoreosteo-conductivematerialthanresorbablepolymer.IncreasedamountsofTCPhavebeenshowninanin-vitrostudy2tostimulatetheproliferationofosteogenouscells.

Composite Material

ThisbrochureispresentedtodemonstratethesurgicaltechniqueutilizedbyJeffereyMichaelson,M.D.BiometSportsMedicine,asthemanufacturerofthisdevice,doesnotpracticemedicineanddoesnotrecom-mendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordeterminingandutilizingtheappropri-atetechniquesforsuchprocedureforeachindividualpatient.BiometSportsMedicineisnotresponsibleforselectionoftheappropri-atesurgicaltechniquetobeutilizedforanindividualpatient.

Surgical Technique

Tunnel PreparationUtilizingatibialguidethatallowsforoptimaltunnelplacement,positionthetibialguideappropriatelyanddrilltheguidewire.Afterthegraftsizehasbeendetermined,reamovertheguidewirewiththecorrespondingreamer.PositionaFemoralAimerintotheover-the–toppositionthroughanaccessoryanteromedialportal(Figure1).

Figure 1

Figure 2 Figure 4

DrillacalibratedguidewirethroughtheFemoralAimerandthelateralcortexofthefemur(Figure2).Considerplacingthescopeintothestandardmedialportaltocheckthattheguidewireisplacedinthe9:30–10:30positionforaleftkneeanda1:30–2:30positionfortherightknee.Drilloverthepreviouslyplacedguidewireanendoscopicreamer

Figure 3

correspondingtothediameterofthegraftdiameterandreamtothedepththatwillallowthedesiredsoft-tissuegraft-to-tunnelinterface(typicallyaround25mm)(Figure3).Drilloverthepreviouslyplacedguidewirewiththe4.5mmToggleLoc™drillbitthroughthelateralcortexofthefemur(Figure4).Passthe4.5mmdrillinandoutofthecortextwotothreetimestofacilitatepassageoftheimplant.

Figure 7

Zip Suture

Figure 5

Prepare ToggleLoc™ Femoral Fixation Device with ZipLoop™ Technology

Surgical Technique (continued)

equalamountsofthesofttissueoneithersideoftheloop.UsethemeasurementpreviouslyobtainedwiththeToggleLoc™depthgaugetomarktheloopsoftheimplanttoensuredeploymentonthelateralcortex.MeasurefromthedistalendoftheToggleLoc™devicetowardthegraftandmarkthelengthwithasurgicalmarker(Figure7).Makeasecondmarkonthegraftbymeasuringthedepthofthe“grafttunnel”(typically25mm).Thismarkwillaidinoptimalgraftpositioninglaterintheprocedure.

PasstheToggleLoc™depthgaugeintothefemoraltunnelandmeasurethetunnellengthfromthelateralcortexofthefemurtothetunnelexitpointinthejointspace(Figure5).PassthesofttissuegraftsthroughbothloopsoftheToggleLoc™FemoralFixationDevicewithZipLoop™Technology(Figure6).Theimplantshouldbeleftinthewhitecardboardpackaging.Thiswillfacilitatepassingthesofttissuegraftthroughthecorrectloops.Placethegraftthroughtheholeinthepackage.Balancethesofttissuegraftsintheloopsoftheimplanttoallow

Figure 6

Threadastrandofrelaysuturethroughtheeyeletofthegraftpassingpinsothatthesutureformsacontinuousloop(Figure8).Pullproximallyontheguidewiretopulltherelaysuturethroughtheskin.Useasuturegrasperorcrochethooktoretrieve(Figure9)therelaysuturethroughthetibialtunnel(Figure10).Loopthepassingsuture(white#2

Figure 8

suturepre-loadedintothetitaniumbutton)oftheToggleLoc™FemoralFixationDevicewithZipLoop™Technologythroughtherelayloop,whichshouldbeexitingthetibialtunnel.Pullproximallyontherelaysuturetopullthepassingsuturethroughthetibialtunnel,jointspaceandfemoraltunnel,exitingthroughtheskin.

Figure 9

Figure 10

Figure 12Figure 11

Surgical Technique (continued)

Insert Implant into TunnelPriortofixation,ensurethattheToggleLoc™FemoralFixationDevicewithZipLoop™Technologyisorientedlaterally,asitwilldeployonthefemur’slateralcortex.The“zipsuture”shouldbeontheanteriorsideofthesoft-tissuegraftpriortograftplacementwithinthefemoraltunnel(Figure11).

PullthepassingsutureproximallyuntilthemarkontheloopsoftheToggleLoc™devicereachtheentranceofthefemoraltunnel.Positiontheimplantjustbeyondthethelateralcortexofthefemur(Figure12).Pullonthedistalendofthesofttissuegraftstofeeltheimplantengageonthelateralfemoralcortex,achievingfemoralfixation.

Zip Suture

Position Graft in Femoral TunnelEnsurethe“zipsuture”isanteriortothegraft.Placetheknotofthezipstrandintotheziplooppuller(Figure13)andpulldistallytodrawthegraftthroughthetibialtunnelandintothefemoraltunnel.ThiswillshortentheloopoftheToggleLoc™FemoralFixationDevicewithZipLoop™Technologyandaccurately

positionthesoft-tissuegraftinthefemoraltunnel.Correctplacementisindicatedwhenthemarkonthegraftentersthefemoraltunnel.Cuttheknotoffoftheendofthe“zipsuture”andretrievethecutsuturelimbsthroughthemedialportal(Figure14).

Figure 13 Figure 14

Tibial FixationPassa1.1mmnitinolguidewirethroughthetibialtunnel.TapthetibialcortexifnecessaryandinsertthedesiredComposiTCP™InterferenceScrewtoachievetibialfixation(Figure15).Ifrequired,tensionthefemoralfixationbypullingonbothlimbsofthezipstrand.

Surgical Technique (continued)

Figure 15

Figure 17

Sever the Zip SuturePassthelimbsofthezipstrandthroughthekeyshapedholeintheSuperMaxCutter™instrument(Figure16).AdvancetheSuperMaxCutter™devicethroughthemedialportalandcutthesutureattheentranceofthefemoraltunnelinthejointspace(Figure17).

Figure 16

Package Insert

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 contact Biomet Sports Medicine at the contact information provided herein.

BiometSportsMedicine 212820154861E.AirportDr. Rev.AOntario,CA91761,USA Date:01/09

Biomet Sports Medicine™ Toggleloc™ Systems

ATTENTION OPERATING SURGEON

DESCRIPTIONTheToggleloc™system isanon-resorbablesystem intended toaid inarthroscopicandorthopedic reconstructiveproceduresrequiringsofttissuefixation,duetoinjuryordegenerativedisease.

MATERIALSTitaniumAlloyUltra-HighMolecularWeightPolyethylene(UHMWPE)PolypropyleneNylonPolyesterStainlessSteel

INDICATIONS FOR USETheToggleLoc™SystemDevicesareintendedforsofttissuetobonefixationforthefollowingindications:

ShoulderBankartlesionrepairSLAPlesionrepairsAcromio-clavicularrepairCapsularshift/capsulolabralreconstructionDeltoidrepairRotatorcufftearrepairBicepsTenodesis

Foot and AnkleMedial/lateralrepairandreconstructionMid-andforefootrepairHalluxvalgusreconstructionMetatarsalligament/tendonrepairorreconstructionAchillestendonrepairAnkleSyndesmosisfixation (Syndesmosisdisruptions)andasanadjunct inconnectionwith traumahardware forWeberBandCanklefractures(only for ToggleLoc™ with Tophat)

ElbowUlnarorradialcollateralligamentreconstructionLateralepicondylitisrepairBicepstendonreattachment

KneeACL/PCLrepair/reconstructionACL/PCLpatellarbone-tendon-bonegraftsDouble-TunnelACLreconstructionExtracapsularrepair:MCL,LCL,andposteriorobliqueligamentIlliotibialbandtenodesisPatellartendonrepairVMOadvancementJointcapsuleclosure

Hand and WristCollateralligamentrepairScapholunateligamentreconstructionTendontransfersinphalanxVolarplatereconstruction

HipAcetabularlabralrepair

CONTRAINDICATIONS 1. Infection. 2. Patientconditionsincludingbloodsupplylimitations,andinsufficientquantityorqualityofboneorsofttissue. 3. Patientswithmentalorneurologicconditionswhoareunwillingorincapableoffollowingpostoperativecare

instructions. 4. Foreignbodysensitivity.Wherematerialsensitivityissuspected,testingistobecompletedpriortoimplanta-

tionofthedevice.

WARNINGSTheToggleloc™ systemof devices provide the surgeonwith ameans to aid in themanagement of soft tissue tobonereattachmentprocedures.While thesedevicesaregenerallysuccessful inattainingthesegoals, theycannotbeexpectedtoreplacenormalhealthyboneorwithstandthestressplaceduponthedevicebyfullorpartialweightbearingorloadbearing,particularlyinthepresenceofnonunion,delayedunion,orincompletehealing.Therefore,it is important that immobilization (use of external support, walking aids, braces, etc.) of the treatment site bemaintaineduntilhealinghasoccurred. Surgical implantsaresubjecttorepeatedstresses inuse,whichcanresultinfractureordamagetotheimplant.Factorssuchasthepatient’sweight,activitylevel,andadherencetoweightbearingorloadbearinginstructionshaveaneffectontheservicelifeoftheimplant.Thesurgeonmustbethoroughlyknowledgeablenotonlyinthemedicalandsurgicalaspectsoftheimplant,butalsomustbeawareofthemechanicalandmetallurgicalaspectsofthesurgicalimplants.

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

1. Correctselectionoftheimplantisextremelyimportant.Thepotentialforsuccessinsofttissuetobonefixationisincreasedbytheselectionofthepropertypeofimplant.Whileproperselectioncanhelpminimizerisks,nei-therthedevicenorgrafts,whenused,aredesignedtowithstandtheunsupportedstressoffullweightbearing,loadbearingorexcessiveactivity.

2. Theimplantscanloosenorbedamagedandthegraftcanfailwhensubjectedtoincreasedloadingassociatedwithnonunionordelayedunion.Ifhealingisdelayed,ordoesnotoccur,theimplantortheproceduremayfail.Loadsproducedbyweightbearingandactivitylevelsmaydictatethelongevityoftheimplant.

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

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

5. Careistobetakentoinsureadequatesofttissuefixationatthetimeofsurgery.Failuretoachieveadequatefixationorimproperpositioningorplacementofthedevicecancontributetoasubsequentundesirableresult.

6. Theuseofappropriateimmobilizationandpostoperativemanagementisindicatedaspartofthetreatmentuntilhealinghasoccurred.

7. Correcthandlingofimplantsisextremelyimportant.Donotmodifyimplants.Donotnotchorbendimplants.Notchesorscratchesputintheimplantduringthecourseofsurgerymaycontributetobreakage.

8. DONOTUSEifthereisalossofsterilityofthedevice.9.DiscardandDONOTUSEopenedordamageddevices,anduseonlydevicesthatarepackageinunopenedor

undamagedcontainers.10. Adequatelyinstructthepatient.Postoperativecareisimportant.Thepatient’sabilityandwillingnesstofollow

instructionsisoneofthemostimportantaspectsofsuccessfulfracturemanagement.Patientseffectedwithsenility,mentalillness,alcoholism,anddrugabusemaybeatahigherriskofdeviceorprocedurefailure.Thesepatientsmayignoreinstructionsandactivityrestrictions.Thepatientistobeinstructedintheuseofexternalsupports,walkingaids,andbracesthatareintendedtoimmobilizethefracturesiteandlimitweightbearingorloadbearing.Thepatientistobemadefullyawareandwarnedthatthedevicedoesnotreplacenormalhealthybone,andthatthedevicecanbreak,bendorbedamagedasaresultofstress,activity,loadbearing,orweightbearing.Thepatientistobemadeawareandwarnedofgeneralsurgicalrisks,possibleadverseeffects,andtofollowtheinstructionsofthetreatingphysician.Thepatientistobeadvisedoftheneedforregularpostopera-tivefollow-upexaminationsaslongasthedeviceremainsimplanted.

PRECAUTIONSDonotreuseimplants.Whileanimplantmayappearundamaged,previousstressmayhavecreatedimperfectionsthatwould reduce theservice lifeof the implant. Donot treatwith implants thathavebeen,evenmomentarily,placedinadifferentpatient.

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

IfdevicecontainsMaxBraid™suture,refertomanufacturerpackageinsertforfurtherinformation.

POSSIBLE ADVERSE EFFECTS 1. Nonunionordelayedunion,whichmayleadtobreakageoftheimplant. 2. Bendingorfractureoftheimplant. 3. Looseningormigrationoftheimplant. 4. Metalsensitivityorallergicreactiontoaforeignbody. 5. Pain,discomfort,orabnormalsensationduetothepresenceofthedevice. 6. Nervedamageduetosurgicaltrauma. 7. Necrosisofboneortissue. 8. Inadequatehealing. 9. Intraoperativeorpostoperativebonefractureand/orpostoperativepain.STERILITYTheToggleloc™systemofimplantsaresuppliedsterileandaresterilizedbyexposuretoEthyleneOxideGas(ETO)ifdevicecontainsMaxBraid™PEsuture.Donotresterilize.Donotuseanycomponentfromanopenedordamagedpackage.Donotusepastexpirationdate.

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

CommentsregardingtheuseofthisdevicecanbedirectedtoAttn: RegulatoryAffairs,Biomet, Inc.,P.O.Box587,WarsawIN46581USA,Fax:574-372-3968.

AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated.

AuthorizedRepresentative: BiometU.K.,Ltd. WatertonIndustrialEstate Bridgend,SouthWales CF313XA,U.K.

User undertaking:Theuseracknowledgeshavingreadtheseinstructions,andundertakestoabidebythem.Materials:DUOSORB™:60%β-TriCalciumPhosphate/40%PolyDLacticAcidcomposite.Indications:TheComposiTCP™InterferenceScrewisexclusivelyusedforthefixation,by interference,ofatransplantmadeoutofpureligament,takenoutforinstancefromthehamstringtendon,whenreconstructing theanteriorcruciate ligament.Thescrewsarecannulatedandareavailable indifferentsizes,7thru11-mm.Theyhaveaspecifichead,whichallowsforamoreevendistributionof the torsional stresses.To achieve theoptimal result, theComposiTCP™ Interference Screwshouldbeimplantedusingadedicatedscrewdrivercontainedintheinstrumentationset.Contraindications:Insufficientorpoor-qualitybonestock (includingtumorsandsevereosteoporosis) is likely toaffectscrewpurchase.Acuteinfection.Allergytoimplantmaterial.Conditionslikelytolimitthepatient’sabilityand/orwillingnesstorestrictactivitiesand/ortoadheretoinstructionsduringthehealingandrehabilitationperiod.Adverse side effects:Todate,noadverseeffectshavebeenobservedandreported.Surgical precautions:TheuseoftheComposiTCP™InterferenceScrewrequiressoundknowledgeoftheanatomyandbiomechanicsofthekneejoint,andoflocomotorapparatusreconstructionsurgery.Surgeonswishingtousethedevicemusthavebeenappropriatelytrained.Thepatientmustbeinformedoftheneedfortemporaryrestrictionofactivitiesandoftheprecautionstobetakenfollowingtheinsertionofthescrew.Recommendations for use: 1.TheComposiTCP™InterferenceScrewmustbeusedonlyforligamentreconstruction. 2.Untilgrafthealingiscomplete,fixationbymeansofthisdeviceshouldbeconsideredtobe

temporary,andtheconstructmustnotbesubjectedtoexcessiveloadingorotherstress.Earlystressonthescreworprematureresumptionofactivitymayleadtobacking-out,bending,breakageordisplacementofthescrew.Forthisreason,appropriateimmobiliza-tion,followedbysupervisedmobilization,willberequiredforaperiodof4to6weeksaftersurgery,oruntilthereisclinicalevidenceofgrafthealing.

3.TheComposiTCP™InterferenceScrewmustbecompletelyburiedbelowthejointsurface. 4.TheComposiTCP™InterferenceScrewmustbescrewedinthankstoaspecificscrewdriver.

Nootherscrewdriver,howeversimilarinappearance,mustbeused,sincedoingsomayleadtoscrewbreakage.

5.Drillingdiameterofthebonetunnelmustbe,attheminimum,equaltothatofthescrew. 6.Guidewiremustnotbetwistedorbentpriortoscrewinsertion,sincedoingsomayimpede

screwinsertionorresultinscrewbreakage. 7.TheComposiTCP™InterferenceScrewmustnotbecutoralteredunderanycircumstances. 8.Screwdrivermustnotbesubjectedtobendingstress.Recommendationsfordevicessuppliedsterile:TheComposiTCP™ InterferenceScrewhasbeenGammasterilized (dose25kGy).Prior touseof the device, the“sterile until” date on the packaging should be checked. SBM accepts noresponsibilityorliabilityfortheuseofproductsthatarepasttheirexpirydate.Thepackagingshouldbecheckedfordefectspriortouseofthedevice.Ifinspectionshowsthepackagingtobedamaged,theproductmustbeassumedtobenon-sterile.TheComposiTCP™InterferenceScrewmustnotberesterilized.Anyscrewsthathavebeenremovedfromtheirpackagingandremainedunusedmustbediscarded.Packaging:ComposiTCP™ Interference Screws are supplied individually packaged in double peel-openpacks.Prior to theuseof thedevice, the integrityof thepackagingmustbechecked.All theinformationrequiredbylawisgivenontheboxorthelabelattachedtothepackaging.

Storage conditions:ComposiTCP™InterferenceScrewsaretobestoredatambienttemperature(15-30°C/60-85°F),andnormalrelativehumidity(50-80%).Storageconditionsmustbesuchasnottocompromisetheintegrityofthepackaging.Instrument:Screwdriver for ComposiTCP™ Interference Screws ø 7,8-mm is Ref. 905271, 905273 orLIG9008046.Screwdriver for ComposiTCP™ Interference Screws ø 9,10,11-mm is Ref. 905272, 905274 orLIG9009017.Surgicalinstrumentsaresubjecttowearwithnormalusage.Instruments,whichhaveexperiencedextensiveuseorexcessiveforce,aresusceptibletofracture.Surgicalinstrumentsshouldonlybeusedfortheirintendedpurpose.Itisrecommendedthatallinstrumentsberegularlyinspectedforwearanddisfigurement.Guarantee:The manufacturer’s guarantee does not apply unless the device is used under the normalconditionsspecifiedintheseinstructions.Reporting of adverse events:Any person handling the device (in a commercial or a healthcare capacity) that has foundtheserviceprovidedbySBMand/orthequality, labeling,reliability,safety,efficacyand/ortheperformance of SBM products wanting in any way should notify the SBM representative ordistributor.The representative or distributor shouldpass the complaint on to the SBMQualityManageras quickly as possible, using an adverse event report form.Theminimum information to beprovidedon this formshouldbe:productdescription, cataloguenumber,batchnumber, thenatureof thecomplaintoradetaileddescriptionof theadverseeventand its consequencesforthepatientand/ortheuser.Anyevidencethatwouldfurthertheinvestigation(theimplantconcerned,Xrays,etc…)shouldbesentwith the form. Ifpoor functionordeteriorationofanimplant,oranyfault inthe instructionsforusehave ledtoapatient’soranenduser’shealthbeingdamaged,thiseventshouldbereportedimmediatelybyphoneorfax.Disposal:The device should be disposed of observing the precautions that apply to operating roomwaste.Manufactured For Distributor: Biomet,SportsMedicine, Inc.,56EastBellDrive,POBox587,Warsaw,IN46581USA.Manufactured By:S.B.M.,ZIduMonge–65100LOURDESFrance–Tel:+33(0)562422101/Fax:+33(0)562422100–Website:www.s-b-m.fr.Caution :Federal Law (USA) restricts this device to sale, distribution, or use by or on the order of aphysician.Date of modification: September 2008.

Wecannotbeheld liableforany incidentresultingfromfailuretocomplywiththeprinciplesdescribedintheseinstructions.

Resorbable Interference Screw

Ordering Information

4.5mm Drill Bit904760 Disposable904765 Reusable

ToggleLoc™ Depth Gauge904766

ToggleLoc™ Disposable Kit909846 Includes: 2.4mmx13"DrillPointK-Wire 2.4mmx16"GraftPassingPin ToggleLoc™4.5mmDrillBit 2.4mmx10"DrillPointK-Wire 1.1mmx14"NitinolGuideWire 3.2mmDrillBit ACLBonePlug MarkingPen 6"Ruler

Super MaxCutter™ Suture Cutter900342

ToggleLoc™ Femoral Fixation Device with ZipLoop™ Technology

904755

ToggleLoc™ Femoral Fixation Device with ZipLoop™ Technology System

909848

ToggleLoc™ Fixation Device

Modular Driver905274

Driver Handle900716 BoneDowelHandle900733 RatchetHandle

Modular Taps905049 7mm905050 8mm905051 9mm905052 10mm

Modular Dilators905045 7–8mm905046 9–10mm

Nitinol Wires906849 1.1mmx14"906852 1.1mmx9"

Instrument Case900300

ComposiTCP™ Interference ScrewComposiTCP™ Interference Screw 60% ß-TCP—

Round Head

905256905257905258

9x25mm9x30mm9x35mm

ComposiTCP™ Interference Screw 60% ß-TCP— Fully Threaded

905261905262905263905264

10x30mm10x35mm11x30mm11x35mm

P.O.Box587,Warsaw,IN46581-0587•800.348.9500ext.1501©2009SportsMedicine•www.biometsportsmedicine.com

FormNo.BSM0189.0•REV022809

www.biometsportsmedicine.com

AlltrademarkshereinarethepropertyofBiomet,Inc.oritssubsidiariesunlessotherwiseindicated.

ThismaterialisintendedforthesoleuseandbenefitoftheBiometsalesforceandphysicians.Itisnottoberedistributed,duplicatedordisclosedwithouttheexpresswrittenconsentofBiomet.

Forproductinformation,includingindications,contraindications,warnings,precautionsandpotentialadverseeffects,seethepackageinsertandBiomet’swebsite.

1.DataonfileatBiometSportsMedicine.Benchtestresultsarenotnecessarilyindicativeofclinicalperformance.2.ClementD:“Evaluationofthemechanicalperformanceof60%TCP/40%PLLAinterferencescrewsummaryofavailabledata.”SBMSA,ZIduMonge,

65100Lourdes,France.