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Surgical Technique ESL ® Elliptical Shaped Lumbar Spine System Elliptical Shape Creates a Natural Fit Available in • Unique, Elliptical Design • Interbody Fusion Device • Comprehensive Range of Sizes

ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

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Page 1: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

Surgical Technique

ESL®

Elliptical Shaped Lumbar Spine System

Elliptical ShapeCreates a Natural Fit

Available in

• Unique,EllipticalDesign

• InterbodyFusionDevice

• ComprehensiveRange of Sizes

Page 2: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

Contents

Introduction ................................................Page1

DesignFeatures ..........................................Page2

Instruments ................................................Page3

SurgicalTechnique .....................................Page4

Closure and Postoperative Care ..................Page9

IndicationsforUse .....................................Page9

ProductInformation ...................................Page13

FurtherInformation .....................................Page14

Page 3: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

1

Introduction

TheESL®SpineSystemisdesignedtorestorethe

biomechanicalintegrityoftheanterior,middleandposterior

columnevenintheabsenceoffusionforaprolonged

periodoftimewhenusedasaVBRdevice.Whenusedasa

fusiondevice,theESL®SpinalSystemisdesignedforuse

withautografttofacilitatefusionandintendedforusewith

supplementalfixationsystemsclearedforuseinthelumbar

spine.TheESL®SpinalSystemmayalsobeimplanted

usingtheAccuVision®Systemtoprovidethesurgeonwith

aminimallyinvasiveapproachforposteriororposterolateral

spinalsurgery.

Product Overview

TheESL®Spacer’sanatomicallycorrectshapeandopen

design,coupledwithsubsidenceandretropulsionresistant

features,accommodatesfusionsandcanrestoresagittal

planealignment.TheESL®Spacerhasbeendesignedwith

anellipticalformthatmatchesthecontourshapeofthe

vertebralbody.Bymatchingtheellipticalcurvesofthe

vertebralspacein1.0mmheightincrements,theESL®

Spacerprovidesaneasyinsertion,improvedfit,andstability

withinthevertebralspace.

TheESL®Spacerdesignenablesendplatestobepreserved,

sincetheydonotneedtobecutorreamed.Bysparing

theendplates,subsidenceisinherentlyreduced.The

implant’sserratedteethandellipticalshapeengagethebony

endplates,resistingsheerandrotationalforces.TheESL®

Spaceraccommodatesfusionwithlargecaudalandcranial

openings,andisreadilyfilledutilizingabonemoldcontained

intheinstrumentationkit.

Inadditiontothebonemold,theESL®SpineSystemoffers

anarrayofinstrumentsthataresimpleandintuitivetouse.

ThemodularT-Handlesaredesignedtoquicklyconnect

and disconnect to the ESL® Trialsforeaseofuse.The

color-codedESL® Trialsprovideeasyidentificationwhen

determiningtheappropriateimplantsizeintraoperatively.

TheESL® Implantsareavailablein8-14mmheightsin

PEEK-OPTIMA® (Polyetheretherketone)forradiolucency.

ESL® ImplantsinPEEK-OPTIMA® areavailableinlengths

of21mm,25mmand29mm,providingadditionalsizing

optionstosuitpatientanatomy.Tantalummarkers

helpvisualizeimplantorientationwithinthespine

whenconductingintraoperativeandpostoperative

radiographicassessment.

TheESL® spacers in PEEK-OPTIMA® can be used unilaterally

orbilaterally.Thissurgicaltechniqueillustratestheirusewith

either approach.

TheESL®SpinalSystemisindicatedforvertebralbody

replacementandintervertebralfusion.Whenusedfor

vertebralbodyreplacement,theESL®SpinalSystemis

indicatedforuseinthethoracolumbarspine(i.e.,T1-L5)

forpartialreplacementofadiseasedvertebralbodyresected

orexcisedforthetreatmentoftumorsinordertoachieve

anteriordecompressionofthespinalcordandneuraltissues,

andtorestoretheheightofacollapsedvertebralbody.The

ESL®SpinalSystemisalsoindicatedfortreatingfractures

ofthethoracicandlumbarspine.TheESL®SpinalSystem

isdesignedtorestorethebiomechanicalintegrityofthe

anterior,middle,andposteriorspinalcolumneveninthe

absenceoffusionforaprolongedperiodoftime.

Asanintervertebralbodyfusiondevice,theESL® Spinal

Systemisindicatedforintervertebralbodyfusionatonelevel

ortwocontiguouslevelsinthelumbarspinefromL2toS1

inpatientswithdegenerativediscdisease(DDD)withupto

Grade1spondylolisthesisattheinvolvedlevel(s).DDDis

definedasbackpainofdiscogenicoriginwithdegeneration

ofthediscconfirmedbypatienthistoryandradiographic

studies.Thesepatientsshouldbeskeletallymatureandhave

hadsixmonthsofnon-operativetreatment.

Page 4: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

2

Image To Come

• Implantsare available in the

followinglengths:21mm(short),25mm(medium)and29mm(long)

Design Features

Available in a Wide Range of Sizes

• Implantheightsavailablefrom8mmto14mm in1mmincrements

Unique, Elliptical Design

• Conformstoconcaveshapeofthevertebralbodies

• Providesappropriatelordosiswithsingledesign

• Easyinsertionshapewithbulletednose

Self Distracting Tips

• Easesinsertionpastposteriorlip

• Reducesasurgicalstepbyeliminatingboxchiseling

Endplate Sparing

• Preservingendplateresistssubsidence

• Reducesasurgicalstepbyeliminating endplatecuttingandreaming

Serrated Teeth

• Providesstabilitybyengaging bony endplates

Open Design

• Accommodatesthefusionprocess withlargesuperior/inferioropenings

• Subsidenceresistance• Radiolucentmaterialoffersanaccuratevisualization andassessmentofthefusion

• Providesidealmodulusofelasticityandload sharingattributes

Page 5: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

3

Instruments

Image To Come

8mmBoneRasp

T-Handle

BoneMold

VariousinstrumentsareavailablewiththeESL® SpineSystem

forusebythesurgeontofacilitateimplantationofthedevice.

Mallet

Elliptical Paddle Scraper

Two-PieceInserterDisassembled

Two-PieceInserterassembledandattachedtotheESL® Spacer

TrialSpreader

Page 6: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

4

1. Distraction/Trialing

ALaminaSpreaderisdesignedtoprovidedistraction

toaccommodateendplatepreparationandconfirmthe

appropriate size ESL® Spacer in PEEK-OPTIMA® prior to

implantation.TheLaminaSpreaderisinsertedintothedisc

spacewiththeteethcomingintodirectcontactwiththe

superiorandinferiorlamina.TheLaminaSpreaderisthen

squeezed,providingdistraction.

TheTrialSpreadersarealsodesignedtoprovidedistraction

aswellastoconfirmtheappropriatesizeESL® Spacer

in PEEK-OPTIMA® priortoimplantation.Thetipsofthe

TrialSpreadersareetchedtoindicatetheirheightsizein

millimeters(SeeFigure1).TheTrialSpreaderisinserted

intothediscspacewiththeflatsurfacecomingintodirect

contactwiththevertebralbodyasshowninFigure2.The

TrialSpreaderisthenrotated90°orientingtheflatsof

thetipperpendiculartothevertebralbody(SeeFigure3).

Fluoroscopy can be used to verify the position and

orientationoftheTrialSpreadertippriortoinsertion

of the ESL® Spacer in PEEK-OPTIMA®.

AlloftheTrialSpreadersmatchtheellipticalshapeofthe

ESL® SpacerasshowninFigure4.TheheightoftheTrial

Spreadersmatchesthetipoftheserratedteethofthe

correspondingESL® Spacer in PEEK-OPTIMA®. Greater

stabilityafterimplantationcanbeachievedbyimplantinga

largersizedESL® Spacer(SeeFigure4).

Surgical Technique

Figure1

Figure2

Figure3

Figure4

New in This Step:

TrialSpreader

Page 7: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

5

3. End Plate Preparation

InadditiontothePaddleScrapers,theESL® SpineSystem

alsohasaRaspinstrumentthatcanbeusedtoremove

thediscmaterialandhelppreparetheendplateasshown

inFigure7.

Figure5

Figure6-Rotated90°

2. Disc Space Preparation

ThePaddleScrapersareusedtofacilitatetheremovalof

discmaterial.TheScrapersfeaturecuttingflutesthatallow

theinstrumenttocutintwodirectionsbyrotatingtheQuick

ConnectT-Handleclockwiseandcounterclockwiseasshownin

Figures5and6.

IMPORTANT!BesurethatthePaddleScraperisalwayssecurely

attachedtotheQuickConnectT-Handlepriortoinsertion.

Figure7

New in This Step:

Elliptical Paddle Scraper

8mmBoneRasp

Page 8: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

6

4. Autograft Placement

TheESL® BoneMoldisspecificallydesignedforthe

impactionofautograftorallograftmaterialintothecavity

of the ESL® ImplantinPEEK-OPTIMA® dependingonthe

indication. After the ESL® Implanthasbeenselected,attach

theInserter,thenplaceitintothecorrespondingcavitysizein

the ESL® BoneMold(Figure8).Autograftisimpactedintothe

ESL® Implantusingabonetampinstrumentforaninterbody

indication;allograftmaybeusedinVBRprocedures.

Surgical Technique (Continued)

Figure8

New in This Step:

BoneMold

Page 9: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

7

5. Implant Insertion

TheESL® Inserterisatwo-pieceinstrument(SeeFigure9).

TheInsertersecurelyattachestotheESL® Spacer in

PEEK-OPTIMA® byplacingtheinnershaftintotheouter

shaftandturningtheknurledknobclockwiseengaging

the ESL® Implant(SeeFigure10).

WhentheInserterisattachedtotheESL® Implant,theblack

T-Handlewillbeparalleltotheopentopandbottomofthe

ESL® Implant.TheblackT-Handlewillhelptodeterminethe

orientation of the ESL® Spacerduringimplantation.Impact

the ESL® Implanttothedesiredposition.(SeeFigure11).

IMPORTANT! Do Not Twist or Rotatethetwo-pieceimplant

inserterinstrumentduringorafterimplantinsertion.When

implantingthePEEK-OPTIMA® Implantitisrecommended

toavoidexcessiveimpactionforceduringimplantation.

Ifbeingusedbilaterally,repeatthesamestepsforthe

contralateralside(SeeFigure12).

Figure10

Figure9

Figure11

Figure12

New in This Step:

Two-PieceInserterDisassembled

Page 10: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

8

Figure15

PosteriorMarkers

AnteriorMarkers

Surgical Technique (Continued)

Figure13

Figure14

5. Implant Insertion (Continued)

Additionalgraftmaterialisthenplacedbetweenandbeside

theimplants(SeeFigure13).

Ifbeingusedunilaterally,asingleimplantisutilized

(SeeFigure14).

Imagingcanbeusedtoconfirmthedesiredpositionofthe

ESL® Spacer in PEEK-OPTIMA® priortodisconnectingthe

ImplantInserterfromtheSpacer.SeeFigure15forlocations

ofanterior/posteriortantalummarkersusedforlocatingthe

PEEK-OPTIMA® Spacer.

Page 11: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

9

Aroutinewoundclosureisthenperformed.

• Routinemonitoringofthevitalsigns,andofthe hemodynamicandneurologicstatusofthepatient

• Painmedication

• NGtubesand/orFoleycathetersshouldbediscontinued within24-48hours

• Dietisrestrictedtosmallamountsofliquidsuntilreturn ofbowelfunctioniscompleted

• Thepatientisencouragedtoambulateassoon aspossible.Theindividualsurgeondetermines

activity level

• Bracesaretobeusedaspereachsurgeon’sdiscretion

Indications for UseClosure and Postoperative Care

TheESL®SpinalSystemisindicatedforvertebralbody

replacementandintervertebralfusion.Whenusedfor

vertebralbodyreplacement,theESL®SpinalSystemis

indicatedforuseinthethoracolumbarspine(i.e.,T1-L5)

forpartialreplacementofadiseasedvertebralbodyresected

orexcisedforthetreatmentoftumorsinordertoachieve

anteriordecompressionofthespinalcordandneuraltissues,

andtorestoretheheightofacollapsedvertebralbody.The

ESL®SpinalSystemisalsoindicatedfortreatingfractures

ofthethoracicandlumbarspine.TheESL®SpinalSystem

isdesignedtorestorethebiomechanicalintegrityofthe

anterior,middle,andposteriorspinalcolumneveninthe

absenceoffusionforaprolongedperiodoftime.

Asanintervertebralbodyfusiondevice,theESL® Spinal

Systemisindicatedforintervertebralbodyfusionatonelevel

ortwocontiguouslevelsinthelumbarspinefromL2toS1

inpatientswithdegenerativediscdisease(DDD)withupto

Grade1spondylolisthesisattheinvolvedlevel(s).DDDis

definedasbackpainofdiscogenicoriginwithdegeneration

ofthediscconfirmedbypatienthistoryandradiographic

studies.Thesepatientsshouldbeskeletallymatureandhave

hadsixmonthsofnon-operativetreatment.

TheESL®SpinalSystemisdesignedforusewithautograft

tofacilitatefusionandisintendedforusewithsupplemental

fixationsystemsclearedforuseinthelumbarspine.

TheESL®SpinalSystemmayalsobeimplantedusing

theAccuVision®Systemtoprovidethesurgeonwitha

minimallyinvasiveapproachforposteriororposterolateral

spinalsurgery.

PleaserefertotheAccuVision®SurgicalTechniquefor

instructionsonusingtheminimallyinvasiveinstrumentation.

Page 12: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

10

Indications for Use (Continued)

Description of Device

TheESL®PEEKimplanthasconvextopandbottomsurfaces

tomatchtheanatomicalshapeofthevertebralendplates

withinthevertebralspace.Thetopandbottomsurfacesalso

haveteethtoresistshearandrotationalforcesbyengaging

thebonyendplates.ThePEEKimplantalsohasanopen

designtopromotebonegrowthbetweentheendplatesof

theadjacentvertebralbodies.TheESL®PEEKimplantis

availableinheightsizesfrom8mm-14mmandinthree

lengths,21mm,25mm,and29mm.TheESL®PEEKimplant

ismadefromPEEK-OPTIMA®(aregisteredtrademarkof

InvibioLimited)asdescribedbyASTMF-2026,titanium

alloy(Ti-6Al-4VELI),conformingtoASTMStandardF136,

withtantalumradio-opaquemarkersmadetothestandard

ASTMF-560.InstrumentsfortheESL®SpinalSystemare

madefromstainlesssteelconformingtoASTMStandards

A276,A564,A582,orF899,aluminumconformingto

ASTMStandardB221orB209,orarecomponentsofthe

AccuVision®System.

Instructions for Use

CAUTION:TheESL®SpinalSystemshouldonlybeimplanted

bysurgeonswhoarefullyexperiencedintheuseofsuch

implantsandtherequiredspecializedspinalsurgery

techniques.RefertotheESL®SpinalSystemSurgical

TechniqueManualforcompleteInstructions-for-Use.

RefertotheAccuVision®SystemSurgicalTechnique

forcompleteInstructions-for-Usefortheminimally

invasiveinstrumentation.

Contraindications

Contraindicationsinclude,butarenotlimitedto,infection,

systemic,spinalorlocalized;morbidobesity;signsof

localinflammation;feverorleukocytosis;metalsensitivity/

allergiestotheimplantmaterials;anymedicalorsurgical

conditionwhichwouldprecludethepotentialbenefitofspinal

implantsurgery,suchastheelevationofsedimentationrate

unexplainedbyotherdiseases,elevationofwhitebloodcount

(WBC),oramarkedleftshiftintheWBCdifferentialcount;

grosslydistortedanatomyduetocongenitalabnormalities;

rapidjointdisease,boneabsorption,osteopenia,and/or

osteoporosis (osteoporosis is a relative contraindication

sincethisconditionmaylimitthedegreeofobtainable

correction,theamountofmechanicalfixation,and/orthe

qualityofthebonegraft);anycasenotneedingabonegraft

andfusionorwherefracturehealingisnotrequired;anycase

requiringthemixingofmetalsfromdifferentcomponents;

anypatienthavinginadequatetissuecoverageoverthe

operativesiteorwherethereisinadequatebonestock,bone

quality,oranatomicaldefinition;anycasenotdescribedin

theindications;anypatientunwillingtocooperatewiththe

postoperativeinstructions;anytimeimplantutilization

wouldinterferewithanatomicalstructuresorexpected

physiologicalperformance.

Page 13: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

11

Warnings

Thesurgeonshouldbeawareofthefollowing:

1. Thecorrectselectionoftheimplantisextremely

important.Thepotentialforsuccessisincreasedby

theselectionofthepropersize,shapeanddesignof

theimplant.Thesizeandshapeofthehumanspine

presentslimitingrestrictionsofthesizeandstrengthof

implants.Noimplantcanbeexpectedtowithstandthe

unsupportedstressesoffullweightbearing.

2. Thesurgeonmustensurethatallnecessaryimplants

andinstrumentsareonhandpriortosurgery.Thedevice

mustbehandledandstoredcarefully,protectedfrom

damage,includingfromcorrosiveenvironments.They

shouldbecarefullyunpackedandinspectedfordamage

prior to use.

3. Allinstrumentsmustbecleanedandsterilizedprior

tosurgery.

4. Aswithallorthopaedicimplants,theESL®SpinalSystem

shouldneverbereusedunderanycircumstances.

5. Properimplantselectionandpatientcomplianceto

postoperativeprecautionswillgreatlyaffectsurgical

outcomes.Patientswhosmokehavebeenshowntohave

anincreasedincidenceofnonunion.Therefore,these

patientsshouldbeadvisedofthisfactandwarnedofthe

potentialconsequences.

6. Postoperativecareisimportant.Thepatientshouldbe

instructedinthelimitationsofhis/herimplantandshould

becautionedregardingweightbearingandbodystress

ontheappliancepriortosecurebonehealing.

7. TheESL®SpinalSystemhasnotbeenevaluatedfor

safetyandcompatibilityintheMRenvironment.The

ESL®SpinalSystemhasnotbeentestedforheatingor

migrationintheMRenvironment

Precautions

Preoperative:Onlypatientsthatmeetthecriteriadescribed

in the indications should be selected. Patient conditions

and/orpre-dispositionssuchasthoseaddressedinthe

Contraindications Section should be avoided. Care should be

usedinthehandlingandstorageoftheimplantcomponents.

Theimplantsshouldnotbescratchedorotherwisedamaged.

Implantsandinstrumentsshouldbeprotectedduringstorage

especiallyfromcorrosiveenvironments.Allinstruments

should be cleaned and sterilized before use.

Intraoperative:Anyinstructionmanualsshouldbecarefully

followed.Atalltimes,extremecautionshouldbeused

aroundthespinalcordandnerveroots.Damagetonerves

mayoccurresultinginalossofneurologicalfunctions.

Postoperative:Thephysician’spostoperativedirections

andwarningstothepatientandthecorrespondingpatient

complianceareextremelyimportant.

Detailedinstructionsontheuseandlimitationsofthedevice

shouldbegiventothepatient.Ifpartialweight-bearingis

recommendedorrequiredpriortofirmbonyunion,the

patientmustbewarnedthatbending,looseningorbreakage

ofthecomponentsarecomplicationswhichcanoccuras

aresultofexcessiveorearlyweight-bearingorexcessive

muscularactivity.Theriskofbending,loosening,or

breakageofaninternalfixationdeviceduringpostoperative

rehabilitationmaybeincreasedifthepatientisactive,orif

thepatientisdebilitated,demented,orotherwiseunableto

usecrutchesorothersuchweightsupportingdevices.The

patientshouldbewarnedtoavoidfallsorsuddenjoltsin

spinal position.

Page 14: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

12

Indications for Use (Continued)

Toallowmaximumchancesforasuccessfulsurgicalresult,

thepatientordeviceshouldnotbeexposedtomechanical

vibrationsthatmayloosenthedeviceconstruct.Thepatient

shouldbewarnedofthispossibilityandinstructedtolimit

andrestrictphysicalactivities,especiallylifting,twisting

motionsandanytypeofsportparticipation.Thepatient

shouldbeadvisednottosmokeorconsumealcoholduring

thebonegrafthealingprocess.

Ifanonuniondevelopsorifthecomponentsloosen,

bend,and/orbreak,thedevice(s)shouldberevisedand/

orremovedimmediatelybeforeseriousinjuryoccurs.

Failuretoimmobilizeadelayedornonunionofbonewill

resultinexcessiveandrepeatedstressesontheimplant.

Bythemechanismoffatiguethesestressescancause

eventualbending,loosening,orbreakageofthedevice(s).

Itisimportantthatimmobilizationofthespinalsurgical

sitebemaintaineduntilfirmbonyunionisestablishedand

confirmedbyradiographicexamination.Thepatientmustbe

adequatelywarnedofthesehazardsandcloselysupervised

toensurecooperationuntilbonyunionisconfirmed.

Donotreuseimplants.Whileanimplantmayappear

undamaged,previousstressmayhavecreatedimperfections

thatwouldreducetheservicelifeoftheimplant.Donot

treatpatientswithimplants/devicesthathavebeeneven

momentarilyplacedinorusedonadifferentpatient.

Potential Adverse Effects and Complications

Possibleadverseeffectsinclude,butarenotlimited

to,bending,looseningorfractureoftheimplantsor

instruments;lossoffixation;sensitivitytoametallicforeign

body,includingpossibletumorformation;skinormuscle

sensitivityinpatientswithinadequatetissuecoverageover

theoperativesite,whichmayresultinskinbreakdownand/or

woundcomplications;nonunionordelayedunion;infection;

nerveorvasculardamageduetosurgicaltrauma,including

lossofneurologicalfunction,duraltears,radiculopathy,

paralysisandcerebralspinalfluidleakage;gastrointestinal,

urologicaland/orreproductivesystemcompromise,

includingsterility,impotencyand/orlossofconsortium;

painordiscomfort;bonelossduetoresorptionorstress

shielding,orbonefractureat,aboveorbelowthelevelor

surgery(fractureofthevertebra);hemorrhageofblood

vesselsand/orhematomas;malalignmentofanatomical

structures,includinglossofproperspinalcurvature,

correction,reductionand/orheight;bursitis;bonegraft

donorsitepain;inabilitytoresumeactivitiesofnormaldaily

living;reoperationordeath.

Sterilization

TheESL®PEEKimplantisprovidedsterile.Theproductis

gammaradiationsterilized.Thepackageshouldbeinspected

prior to use to ensure the sterile barrier has not been

compromised.Donotresterilize.

Caution

Federal(USA)lawrestrictsthesedevicestosalebyoronthe

order of a licensed physician.

Page 15: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

13

PEEK-OPTIMA® Implant Loaner Tray Short

(Catalog No. 80982)

Catalog # Implant

60208 8mmShortSpacer

60209 9mmShortSpacer

60210 10mmShortSpacer

60211 11mmShortSpacer

60212 12mmShortSpacer

60213 13mmShortSpacer

60214 14mmShortSpacer

PEEK-OPTIMA® Implant Loaner Tray Medium and Long

(Catalog No. 5500181)

Catalog # Implant

60468 8mmMediumSpacer

60469 9mmMediumSpacer

60470 10mmMediumSpacer

60471 11mmMediumSpacer

60472 12mmMediumSpacer

60473 13mmMediumSpacer

60474 14mmMediumSpacer

60478 8mmLongSpacer

60479 9mmLongSpacer

60480 10mmLongSpacer

60481 11mmLongSpacer

60482 12mmLongSpacer

60483 13mmLongSpacer

60484 14mmLongSpacer

*Productshighlightedareavailableasspecialorder.

Loaner Instrument Tray

(Catalog No. 80980)

Catalog # Instruments

60260 Inserter Inner Shaft

60261 InserterOuterSleeve

60287 T-Handle

60288 8mmTrialSpreader

60289 9mmTrialSpreader

60290 10mmTrialSpreader

60291 11mmTrialSpreader

60292 12mmTrialSpreader

60293 13mmTrialSpreader

60294 14mmTrialSpreader

60295 15mmTrialSpreader

60338 8mmBoneRasp

60277 7mmEllipticalPaddleScraper

60278 8mmEllipticalPaddleScraper

60279 9mmEllipticalPaddleScraper

60280 10mmEllipticalPaddleScraper

60281 11mmEllipticalPaddleScraper

60282 12mmEllipticalPaddleScraper

60283 13mmEllipticalPaddleScraper

60284 14mmEllipticalPaddleScraper

60215 BoneMold

60207 Mallet

Product Information

Page 16: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

14

Further Information

Thisbrochuredescribesthesurgicaltechniqueusedby

PaulS.Lin,M.D.Thesurgeonwhoperformsanyimplant

procedureisresponsiblefordeterminingtheappropriate

product(s)andutilizingtheappropriatetechnique(s)forsaid

implantationineachindividualpatient.Thecontentsofthis

brochureareintendedtobeonlyaguideandarenot

intended to set a standard of care.

Forfurtherinformation,pleasecontacttheCustomerService

Departmentat:

BiometSpine

100InterpaceParkway

Parsippany,NJ07054

973.299.9300•800.526.2579

www.biometspine.com

Page 17: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

15

Notes:

Page 18: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

16

Notes:

Page 19: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System
Page 20: ESL® Elliptical Shaped Lumbar Spine System Surgical Technique · ESL® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® Spinal System

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

100InterpaceParkway•Parsippany,NJ07054800.526.2579•www.biometspine.com•BSP228009L08/10

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ESL® Elliptical Shaped Lumbar Spine System Elliptical Shape Creates a Natural Fit