acl reconstruction— medial portalthread a strand of relay suture through the eyelet of the graft...
TRANSCRIPT
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ACL Reconstruction— Medial Portal
Surgical Protocol by Jefferey Michaelson, M.D.
with ZipLoop™ Technology For ACL Reconstruction
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Features• Auniqueweaveinwhichasinglestrandofbraidedpolyethyleneiswoventhroughitselftwiceinoppositedirections
• ThisconstructallowsBiometSportsMedicinetoproduceinnovativeproductsthatcanvaryinlengthandcompression/tensionaddressingtheindividualneedsofeachpatient
• ProductsutilizingZipLoop™Technologyareresistanttoslippagewithouttyingknots1
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Benefits• Maximizessofttissuegraft-to-tunnelinterface
• Oneimplantforvaryingtunnellengths—eliminatestheneedformultiplesizes
• ForuseinbothtranstibialandanteromedialportalACLreconstruction
• Tensionmaybeappliedfromfemoralsideaftertibialfixationhasbeenachieved
• Virtuallynoslippageaftercyclicloading1
• Simplesurgicaltechniquerequiresminimalinstrumentation
• Femoralfixationdevicedesignedtocapturethecorticalboneofthefemur
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Features• Madefromacompositematerialwithaninnovativeblendof40%PLDLAand60%betaTri-CalciumPhosphatethatisdesignedforsoft-tissuefixation
• Uniquestar-shapeddrivemechanismthatlimitsstressanddistributestorqueevenlyonthescrewduringinsertion1
New… from Biomet Sports Medicine
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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
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ThisbrochureispresentedtodemonstratethesurgicaltechniqueutilizedbyJeffereyMichaelson,M.D.BiometSportsMedicine,asthemanufacturerofthisdevice,doesnotpracticemedicineanddoesnotrecom-mendthisoranyothersurgicaltechniqueforuseonaspecificpatient.Thesurgeonwhoperformsanyprocedureisresponsiblefordeterminingandutilizingtheappropri-atetechniquesforsuchprocedureforeachindividualpatient.BiometSportsMedicineisnotresponsibleforselectionoftheappropri-atesurgicaltechniquetobeutilizedforanindividualpatient.
Surgical Technique
Tunnel PreparationUtilizingatibialguidethatallowsforoptimaltunnelplacement,positionthetibialguideappropriatelyanddrilltheguidewire.Afterthegraftsizehasbeendetermined,reamovertheguidewirewiththecorrespondingreamer.PositionaFemoralAimerintotheover-the–toppositionthroughanaccessoryanteromedialportal(Figure1).
Figure 1
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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.
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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
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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
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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
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Position Graft in Femoral TunnelEnsurethe“zipsuture”isanteriortothegraft.Placetheknotofthezipstrandintotheziplooppuller(Figure13)andpulldistallytodrawthegraftthroughthetibialtunnelandintothefemoraltunnel.ThiswillshortentheloopoftheToggleLoc™FemoralFixationDevicewithZipLoop™Technologyandaccurately
positionthesoft-tissuegraftinthefemoraltunnel.Correctplacementisindicatedwhenthemarkonthegraftentersthefemoraltunnel.Cuttheknotoffoftheendofthe“zipsuture”andretrievethecutsuturelimbsthroughthemedialportal(Figure14).
Figure 13 Figure 14
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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
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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.
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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
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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
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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.