solitaire -c cervical spacer system - zimmer biomet...1 introduction the solitaire -c cervical...
TRANSCRIPT
Surgical Technique
Solitaire™-C Cervical Spacer System
A Zero Profile Anterior Cervical Fusion Device
Large Graft Cavity and Multiple Footprint Options• Largeautograftcavityencouragesoptimal
healingenvironment• Comprehensiveofferingswiththree
spacerfootprints
Unique Spacer Band• Assistsdeviceplacementwithaccurate
radiographicvisualization• Color-codedwithscrewstoidentifyappropriate
screwdepth
Sophisticated Instruments Simplify Implantation• Uniqueinserterguideprovidesclearvisualization
ofholepreparationforscrewinsertion• Multiplescrewinserteroptions
B
Introduction ................................................ Page1
ProductOverview ........................................ Page2
FeaturesandBenefits .................................. Page3
Implants ...................................................... Page4
Instruments ................................................ Page5
SurgicalTechnique ..................................... Page9
Removal ...................................................... Page21
OrderingInformation .................................. Page22
Contents
IndicationsforUse ...................................... Page28
Contraindications ........................................ Page28
Warnings .................................................... Page28
Precautions ................................................. Page29
PotentialAdverseEffectsandComplications ...................................... Page30
Sterilization ................................................. Page30
FurtherInformation ..................................... Page31
1
Introduction
TheSolitaire™-CCervicalSpacerSystemisusedfor
stand-aloneanteriorcervicalinterbodyfusionprocedures
inskeletallymaturepatients.Itoffersseveraluniquefeatures
includingalargegraftcavity,threefootprintsizes(inboth
lordoticandparallel),auniquecolor-codedbandaroundthe
implantforeasierscrewidentification,andasophisticated
yetsimpleinstrumentationsystem.TheSolitaire™-CSystem
alsoofferstwolockingscrews(3.5mmand3.75mm)and
zeroprofileintheanteriorcervicalspine.
Thistechniqueguidedescribesasurgicaltechniqueusedby:
Todd J. Albert, M.D.
RichardRothmanProfessorandChair
DepartmentofOrthopaedicSurgery
ProfessorofNeurosurgery
Philadelphia,PA
J. Abbott Byrd, III, M.D.
StaffSurgeonandPresident
VirginiaBeach,VA
Andrew T. Dailey, M.D.
DepartmentofNeurosurgery
SaltLakeCity,UT
Yong H. Kim, M.D.
ClinicalAssistantProfessor
NewYork,NY
K. Daniel Riew, M.D.
Chief,CervicalSpineSurgery
StLouis,MO
Thesurgeonwhoperformsanyimplantprocedureis
responsiblefordeterminingtheappropriateproduct(s)and
utilizingtheappropriatetechnique(s)forsaidimplantationin
eachindividualpatient.
CAUTION:FederalLaw(USA)restrictsthisdevicetosale
byorontheorderofaphysician.
2
Solitaire™-C Spacers
TheSolitaire™-CSpacersarecomposedofaTitaniumalloy
faceplate,PEEK-OPTIMA®body,tantalummarkers,anda
Titaniumalloyband.TheTitaniumfaceplatesarecolor-coded
todenoteheight(seechartbelow).TheTitaniumbandsare
color-codedtodenotedepth.
Spacer Height Color
6mm Dark Green
7mm LightMagenta
8mm DarkBlue
9mm Gold
10mm Bronze
Spacer Depth Screw Length Color
12mm 12mm LightGreen
14mm 14mm Gold
15mm 15mm LightMagenta
Product Overview
Screws
Screwsareplacedatafixedtrajectoryof35°cephalad/
caudaland7°medial/lateral.Thescrewlengthisdefinedas
thedistance(inthelateralview)fromtheanteriorfaceofthe
spacertothetipofthescrew.Screwsarealsocolor-codedby
lengthwhichisdesignedtomatchspacerdepthandthecolor
oftheimplantband.Twoscrewsareintendedtobeplaced
intoeachspacersuchthatonescrewattachesthespacerto
thesuperiorvertebralbodyoftheaffectedlevelandtheother
screwattachesthespacertotheinferiorvertebralbodyofthe
affectedlevel.Screwslocktothetitaniumfaceplatebywayof
athreaded,cam-stylelockingmechanismthatistorquedwith
aminimumof14in.-lbs.tolockthescrewsinplace.Screws
aremanufacturedfromTitaniumalloy.
Screwsareofferedin3.5mmand3.75mmdiameters.The
3.5mmscrewsarefullycolored,whilethe3.75mmscrews
haveonlytheirheadscolored(whilethethreadsaresilver).
3
Features and Benefits
Large Graft Cavity and Multiple Footprint Options
• Largeautograftcavityencouragesoptimalhealingenvironment
• Comprehensiveofferingswiththreespacerfootprints
Unique Spacer Band
• Assistsdeviceplacementwithaccurateradiographicvisualization
• Color-codedwithscrewstoidentifyappropriatescrewdepth
Sophisticated Instruments Simplify Implantation
• Uniqueinserterguideprovidesclearvisualizationofholepreparationforscrewinsertion
• Multiplescrewinserteroptions
12mm 14mm 15mm
4
Implants
14mm
Spacers:
Footprint: 14mm(wide)x12mm(deep)
Heights:6.0mm–10mm(1.0mmincrements)
Shapes:ParallelandLordotic(7°)
Footprint:16mm(wide)x14mm(deep)
Heights:6.0mm–10mm(1.0mmincrements)
Shapes:ParallelandLordotic(7°)
Footprint:18mm(wide)x15mm(deep)
Heights:6.0mm–10mm(1.0mmincrements)
Shapes:ParallelandLordotic(7°)
Screws:
Length:12mm,14mm,15mm
Diameter:3.5mm
Length:12mm,14mm,15mm
Diameter:3.75mm
NOTE:Screwlengthisdefinedasthedistanceinthelateral
viewfromtheanteriorfaceofthespacertothetipofthe
screw.Thismeansscrewdepthwillbeequivalenttospacer
depthwhencorrespondingsizesareused.
5
Instruments
Trials
Rasps
Slim Inserter Guide
Open Inserter Guide
Inserter Handle
12mm Angled Awl
Fixed Angled Driver (45°)
Includes:
- AngledScrewDriverBit
- AngledDrillBit
- FixedAngledDriver
6
Tip with Malleable Shaft
Fixed Angle Bit Remover
Drill/Awl Sleeve
Spring-Loaded Drill/Awl Sleeve
Straight Drills
Straight Awls
Quick Connect Handle
Instruments (Continued)
7
Non-Retaining Flexible Driver
Threaded Screw Inserter
Torque Wrench Handle
Slide Hammer
Includes:
- SlideHammerAdapter
Driver Sleeve Family
Includes:
- DriverSleeve
- DriverforSleeves
- DriverSpringSleeve
Auto-Centering Driver
Non-Retaining Driver
Flexible Driver
8
Instruments (Continued)
Slotted Mallet
Graft Packing Caddy
Implant Remover
Includes:
- InnerShaft
- ImplantRemover
9
Surgical Technique
Step 1: Vertebral Body Distraction
Ifusingdistractionpins,placeonedistractionpininthe
vertebralbodysuperiortotheaffectedlevelandtheother
distractionpininthevertebralbodyinferiortotheaffected
level.ThePinDistractorisplacedoverthepinsandopened
asneededtodistractthevertebralbodies(beingcarefulnot
toover-distractthesegment).
Step 2: Discectomy and End-Plate Preparation
Usingrongeurs,pituitariesandcurettes,removethe
intervertebraldiscandosteophytesasneeded.Rasps
canalsobeusedtopreparetheendplatesandexpose
bleedingbone.
TheSolitaire™-Ctrialsandraspsaredouble-sidedfor
efficiency.Theseinstrumentscorrespondtotheimplant
footprintsandareavailablein5.0mm–10mmheightsin
1.0mmincrementssimilartotheimplants.(Pleasenote
thatthereisa5.0mmtrialandrasp,butthatheightisnot
availableinanimplant).
Also,theraspsaredesignedsothattheteethcutonthe
backstrokeastheinstrumentisbeingpulledawayfromthe
spinalcord.
NOTE:Aggressivepreparationoftheendplatemayremove
excessiveboneandweakentheendplate.
Usingastandardsurgicalapproach,exposethevertebral
bodiestobefused.Traditionalcervicalretractorsmaybe
used.Preparethefusionsitefollowingtheappropriate
techniqueforthespecificindication.
Figure1
Figure2
10
Surgical Technique (Continued)
Step 3: Implant Sizing
Usingthedouble-sidedraspsortrials,determinethe
appropriateimplantsizebysizingthediscspace.When
sizing,useincrementallylargersizesuntilatightfitis
achieved.Asecurefitisdesirabletomaintaindischeightand
stabilizethesegment,sothereshouldbenogapsbetween
thepreparedsiteandtrialorrasp.
Thetrialsandraspsarebothavailablewithorwithoutstops.
Thestopsallowforamaximumof2.0mmofcountersinkinto
thediscspace.
Oncethedesireddischeightisdetermined,selectthe
appropriateSolitaire™-Cimplant.Raspsandtrialshave
sleevesthatarecolor-codedtomatchtheheightofthe
correspondingspacer.
NOTE:Thetrial,raspandimplantheightsforeachparticular
sizeareallequal.Implantheightismeasuredtothesuperior/
inferiorsurfacesoftheTitaniumfaceplateandpeaksofthe
PEEK-OPTIMA®bodymacro-texture.Raspsaremeasuredto
thepeaksoftheteeth.
Step 4: Inserter Guide Assembly and Implant Attachment
TheSolitaire™-Csystemofferstwoinserterguideoptions,
slimandopen,thatthreadontotheinserterhandleand
facilitatescrewholepreparationandscrewinsertion
throughthesameinstrument.Bothguideoptionsallow
forvisualizationoftheimplant/endplateinterfaceand
screwinsertion.
Slim Inserter Guide
Thesliminserterguideprovidesvisualizationtothefrontof
thespaceronalateralx-ray.Thisinserterguidecanbeused
toplacescrewswithorwithoutholepreparation.Drill/Awl
andScrewsleevescanbeusedwiththisguide.
Open Inserter Guide
Theopeninserterguideprovidesmorevisualizationthanthe
sliminserterguide.Alldrivers,awlsanddrillsmustbein
contactwiththeguidearcduringuse.
NOTE:BiometSpinedoesnotrecommendfreehanding
Solitaire™-Cscrews.
11
Selecttheinserterguide(openorslim)thatcorresponds
tothefinalimplantsizetobeused.Eachimplantwidthand
heighthasacorrespondingguidetipwhichiscolor-coded
tomatchaparticularspacerheight.Thereisastoponone
sideoftheinserterguidetofacilitateplacingthespacer
ata2.0mmcountersinkrelativetotheanteriorfaceofthe
vertebralbody.Thestopcanbeorientedinasuperioror
inferiordirectionbasedonsurgeonpreference.
Attachtheinserterguidetotheinserterhandlebythreading
thedistaltipoftheinserterhandlecompletelythroughthe
threadedholeoftheinserterguide.Theinserterguidewillbe
looseontheinserterhandleuntilthespacerisattached.
Alignthespacertotheinserterguide.Sincetheimplant
andtheinserterguidearebothrotationallysymmetric,
thesuperiorandinferiorsurfacesofbothdevicesare
interchangeable.Turntheinserterhandletothreadtheinner
shaftintothethreadedholeinthecenterofthespaceruntil
theassemblyisrigid.
O.R. Tip:Confirmproperorientationofguidetoimplantby
insertingadriverwithacenteringsleeveoptiondownoneof
theinserterguidetubes.Theinstrumentshouldeasilyseat
intotheguidewithnomanipulation.
Autograft Packing
Oncetheimplantisattachedtotheinserter,fillthecavitywith
autograft.Thegraftpackingcaddycanbeused.
12
Surgical Technique (Continued)
Step 5: Implant Insertion
Impacttheimplantintothefusionsitebystrikingthe
proximalendoftheinserterhandle.Theslidehammerwith
adaptercanalsobeusedforinsertion.
EachimplantcontainstwoTantalummarkers1.0mmfrom
theposteriorwalloftheimplantthatcanbeusedasa
referencewhenusingfluoroscopy.
Additionally,theSolitaire™-CSpacerincorporatesauniquely
designedtitaniumbandaroundthespacerwhichassistswith
radiographicvisualizationatthefusionsite.
Releaseanydistractorsinusetoensurethattheimplantis
fullyengagedwithendplates.
Step 6: Screw Hole Preparation
Avarietyofdrills,awlsandcenteringsleevesareavailable
toaidinscrewholepreparationinordertomeet
anatomicalchallenges.
Awl and Drill Options
Straightawlsandstraightdrillsareavailablein12mm,14mm
and15mmlengthsandcorrespondtoequivalentscrew
lengths.Likethescrews,drilldepthismeasuredinthelateral
viewfromtheanteriorfaceofthespacertothetipofthedrill
orawl.Severalguidesleeveoptionsareavailablefordrills
aswellasawls.Additionally,drillsandawlsarecolor-coded
toaidininstrumentidentificationandensureproperdepth.
Straightdrillsandawlsarecolor-codedtomatchscrew
length.Angleddrillbitshavetheirowncolor-codingscheme.
12mm 14mm 15mm
Screws LightGreen Gold LightMagenta
Straight Drill LightGreen Gold LightMagenta
Straight Awl LightGreen Gold LightMagenta
Angled Drill Bit Silver Gold DarkGray
13
Thestraightdrill,straightawlandangledawl(45°)are
designedtoconnectdirectlytothequickconnecthandle.
Theangleddrillbitmustbeattachedtothefixedangledriver
(45°).Thisdrivermateswiththequickconnecthandle.
Toattachtheangleddrillbittothefixedangledriver(45°),
lineupthemalesquareofthedriverwiththefemalesquare
withinthebit.Whenthesquaresarealigned,themalesquare
onthedriverwillsitdeeperinthebit.Oncethesquaresare
aligned,applyforcetoseatthecantileverspringsonthebit
overtheretentionbumponthedriver.Theangleddrillbitwill
beretainedonthefixedangledriver(45°)untilitisremoved
withthefixedangledbitremoverasdescribedlaterin
thetechnique.
Angled Drill Bit Fixed Angled Driver (45°)
NOTE:Theoutersleevemustbeassembledontotheinner
shaftofthefixedangledriver(45°).Slidetheoutersleeve
overtheinnershaftandseatthefemalehexoverthemale
hexpriortoattachingthehandle.
Angled Awl
Anangledawlisavailableina12mmlengthandisnot
color-coded.Itdoesnotrequireanadditionalguidesleeve.
Thereisahardstopbetweentheawlandtheinsideofthe
faceplateonthespacer.
Theangledawlhasalaseretchedmarkingthatdisappears
insidetheinserterguidewhentheawlisfullyseatedinthe
spacerandatthecorrectdepth.
14
Surgical Technique (Continued)
Centering Sleeve Options
Thefollowingcombinationsofdrills,awls,andsleevesareavailable:
Stra
ight
Aw
l
Stra
ight
Dril
l
Angl
ed D
rill B
it w
hich
atta
ches
to th
e F
ixed
Ang
le D
river
Drill/Awl Sleeve
X X
Spring-Loaded Drill/Awl Sleeve
X X
Tip with Malleable Shaft (For Angled Drill. Must be used with Slim Inserter Guide.)
X
Short Centering Tip* (For Angled Drill. Must be used with slim inserter guide.)
X
NOTE:Allguidetubesortipsmustberemovedbeforescrewinsertion.
NOTE:Drillandawloptionsareusedwithcenteringsleevestoaidinscrewholepreparation.
*Specialorderinstrument
Drill/Awl Sleeve
Thissleeveisplaceddirectlyintoeitherstyleinserterguide
afterimplantinsertion.Straightawlsanddrillscanbeused
withthisinstrument.Bothhaveapositivehardstopjust
belowthecolor-codedbossthatcontactsthetopofthis
sleeve.Thissleevehasalaseretchedmarkingthatdisappears
insidetheinserterguidewhenitisfullyseatedinthespacer
andatthecorrectdepth.
Spring-Loaded Drill/Awl Sleeve
Thissleeveisintendedtobepre-attachedtostraightdrills
andawlspriortoinsertionintotheinserterguide.Both
straightdrillsandawlshaveabumpmid-wayalongtheshaft.
Toproperlyattachthespringsleeve,slidethesleeveontothe
straightdrillorawluntilthecantileverspringsonthespring
sleeveslideoverthebump.Nowthespringsleeveisretained
onthestraightdrillorawl.Toremovethesleeve,slideitover
thebumpintheoppositedirection.
Standarddrillsandawlshaveapositivehardstopjustbelow
thecolor-codedbossthatinteractswiththisguidetube.This
sleevehasalaseretchedmarkingthatdisappearsinsidethe
inserterguidewhenitisfullyseatedinthespacerandatthe
correctdepth.
Tip with Malleable Shaft for Angled Drill
Thetipwithmalleableshaftcanbeusedwithanystraightawl
ordrilloptionbutisprimarilyusedwiththeangleddrillbits.
Itisintendedtobeplaceddirectlyintotheinserterguideprior
toinsertingadrill.Ithasamalleablenitinolhandlethatcan
bepositionedtohelpavoidanatomicalchallenges.Angled
drillshaveavisiblehardstopthatcontactsthetopofthis
guide.Straightdrillsandawlshaveaninternalstop.
O.R. Tip:Whenusingthetipwithmalleableshaft,it
maybehelpfultoplaceitintotheinserterguideprior
toimplantinsertion.
15
16
Surgical Technique (Continued)
Thefollowingdriveroptionsareavailable:
Threaded Screw Inserter
Thethreadedscrewinserterallowsforarigidscrew
attachmenttotheinserter.Theinternalthreadatthedistal
endoftheinsertermateswiththeexternalthreadonthehead
ofthescrew.Thethreadedscrewinserterisself-centering
whenusedwiththeslimguides.Ifusingtheopenguide,the
screwinsertershouldcontacttheguidearcasthescrewis
advancedtoensureproperscrewplacement.
Auto-centering Driver
Thisisastab-and-grabdriver.Ithasanincreasedshaft
diameteratthedistalendoftheDriver.Thisincreased
diameterworkswiththesliminserterguidetohelpensure
thatthescrewheadisproperlycenteredasitentersintothe
titaniumfaceplateofthespacer.Ifusingtheopenguide,the
auto-centeringdrivershouldcontacttheguidearcasthe
screwisadvancedtoensureproperscrewplacement.
Short Centering Tip for Angled Drill
Thecenteringtipisusedwiththeangleddrillbits.Itis
intendedtobeplaceddirectlyintothesliminserterguide
priortoinsertingadrill.Theangleddrillshaveavisiblehard
stopthatcontactsthetopofthisguide.Thecenteringtipalso
hasasmallholeattheproximalendofthetiptoaccepta
suturewhichwillaidinremovalafteruse.Asutureshouldbe
placedintheloopoftheshortcenteringtippriortouse.
NOTE:Theshortcenteringtipisnotapartofthekit,butis
availableasaspecialorderitemonly.
Screw Driver Options
Multiplescrewdriveroptionsareavailabletoaidinscrew
placementandhelpmeetsurgeonneedsandpreferences.All
drivershaveahexalobeinterfaceatthedistaltipandaquick
connectgeometryattheproximalendwhichengageswitha
quickconnecthandleortorquelimitinghandle.Alldriversare
compatiblewithboththeopenandsliminserterguides.
NOTE:Whenusingtheopeninserterguide,ensurethe
driverisincontactwiththearcoftheguideasthescrew
isadvanced.
17
Driver Sleeve
Driver Spring Sleeve
Driver for Sleeves
Thisdriverisastab-and-grabdriverthatisusedwith
sleevestohelpensurethatthescrewisenteringthetitanium
faceplateofthespacercenteredandatthepropertrajectory.
Boththedriverandthesleeveshavedarkgraycolor-coding
tohelpdifferentiatethemfromthedrill/awlsleevesand
denotethattheyshouldbeusedtogether.Likethedrilland
awlsleeves,thisdrivercanbeusedwiththedriversleeveor
thedriverspringsleeve.Thedriversleeveisplaceddirectly
intotheinserterguide.Thedriverforsleevescanthenbe
passeddownthissleevetoinsertthescrew.Alternatively,
thedriverspringsleeveisintendedtobepre-attachedtothe
driverforsleevespriortoinsertionintotheinserterguide.
Thestraightdriverforsleeveshasabumpmid-wayalong
theshaft.Toproperlyattachthedriverspringsleeve,slide
thesleeveontothedriveruntilthecantileverspringsonthe
springsleeveslideoverthebump.Nowthespringsleeveis
retainedonthedriver.Toremovethesleeve,slideitoverthe
bumpintheoppositedirection.
Driver Sleeve Family
Includes:
- DriverSleeve
- DriverforSleeves
- DriverSpringSleeve
18
Surgical Technique (Continued)
Non-Retaining Driver
Thisdriverdoesnotfrictionallylocktothescrewsand
hasagoldtiptohelpdenotethatitisnotintendedtobe
stab-and-grab.Becauseitisnotastab-and-grab,this
driversitsdeeperintothescrew’shexalobedrivegiving
thedriver-to-screwinterfacemorestrength.Italsohasa
decreasedshaftdiameteratthedistalendofthedriver.
Thisallowsforadditionalversatilitywhichmaybe
necessaryduringscrewremovalorrevisioncases.
O.R. Tip:Allgold-tipdriversarenotintended
tobestab-and-grab,andwillnotretainthescrew.
Thegold-tipdriversareintendedforfinaltightening
orremoval.
O.R. Tip:Usinganon-retainingdriverduringfinaltightening
andscrewremovalcanreducethechanceofstrippingthe
screworthedriver.
Fixed Angle Driver (45°) and Angled Driver Bits
Thisangleddriveroptionhasastab-and-grabscrewinterface
aswellasarigidfixedangletoaidinscrewplacementand
helpaddressanatomicalchallengeswhichcanbefoundinthe
upperandlowerregionsofthecervicalspine.Driverbitsare
intendedtoattachtothefixedangleddriver.Todoso,lineup
themalesquareofthedriverwiththefemalesquarewithin
thebit.Whenthesquaresarealignedthemalesquareonthe
driverwillsitdeeperinthebit.Oncethesquaresarealigned
applyforcetoseatthecantileverspringsonthebitoverthe
retentionbumponthedriver.Thebitwillberetainedonthe
driveruntilitisremovedusingthebitremoverdescribedlater
inthistechnique.
Flexible Driver
Thisalternateangleddriveroptionhasastab-and-grabscrew
interfaceaswellasrobustflexiblelinks.Thisinstrument
contourstotheanatomyandhelpsaddressanatomical
challengeswhichcanbefoundintheupperandlowerregions
ofthecervicalspine.
19
Non-Retaining Flexible Driver
Thisdrivercombinesthebenefitsoftheflexibledriverwith
theversatilityofthenon-retainingdriver.Itisnotintendedto
beastab-and-grabdriver(goldtip),asitdoesnotfrictionally
engagewiththescrew.
Step 7: Screw Insertion
Reminder:Screwsareplacedatafixedtrajectoryof35°
cephalad/caudalandhavea7°medialconvergence.Theslim
guideswillfacilitatethistrajectory.Whenusingtheopen
guides,ensuretheinsertershaftremainsincontactwiththe
guidearctoensurethepropertrajectory.
Attachthequickconnecthandletothedesireddriveror
threadedscrewinserter.
Whenusingastab-and-grabdriver,affixthedesiredsize
screwtothedriverbyseatingthedistaltipofthedriverinto
thehexalobeonthescrewhead.Placethescrewintothe
appropriatescrewholethroughtheinserterguide.Inserteach
screwuntilsolidengagementofthecancellousthreadoccurs.
Repeatforthecontralateralhole.
When using the threaded screw inserter
Affixthedesiredsizescrewtothethreadedscrewinserterby
turningthescrewclockwisetomatetheexternalthreadon
thescrewheadwiththeinternalthreadofthescrewinserter
untilthescrewbottomsout.Insertthehexalobeonthedistal
tipoftheinserterintotheheadofthescrew.
Placethescrewintotheappropriatescrewholethrough
theinserterguide.WhileholdingtheT-handleofthescrew
insertersteady,turnthestraightquick-connecthandle
clockwisetoadvancethescrewoutofthesleeveandinto
thefaceplateofthespaceruntilsolidengagementofthe
cancellousthreadoccurs.Repeatforthecontralateralhole.
20
Surgical Technique (Continued)
Step 8: Final Tightening
Attachthetorquewrenchhandletothedesireddriverand
insertthetipofthedriverintothehexalobedriveofthe
screw.Turnthehandleuntilanaudible“click”isheardat
(aminimumof)14in.-lbs.oftorque.
O.R. Tip:Theinserterguideshouldremainengaged
duringscrewinsertionandfinaltighteningtoserveas
acountertorque.
O.R. Tip:Torquewrenchcanbeattachedtothedriveratthe
beginningofthescrewinsertionprocess,ifpreferred,so
thereisnoneedtoswitchhandles.
NOTE:Biometdoesnotrecommendusingthefixedangle
driverforfinaltightening.Anyotherdriveroption(including
theflexibledriver)canbeusedforfinaltorquing.
Step 9: Inserter Guide Removal
Turntheinserterguidehandlecounterclockwiseuntilit
disengagesfromthespacer.Thetipwillbelooseontheshaft
butwillberetainedontheshaft.
21
Removal
Angled Driver Bit Removal
Thedriverbitand/ordrillbitsplacedonthefixedangledriver
shouldberemovedusingtheangleddriverbitremover.To
removeabit,lineupthelaseretchedlinesonthebitremover
andfixedangledriverhousing.Then,placethebitthrough
thecustomtipsoftheremoveruntilthefaceofthetips
contactthehousingofthefixedangledriver.Squeezethe
handlesoftheremovertodisengagethebit.
Implant Removal
ShoulditbecomenecessarytoremovetheSolitaire™-C
Spacer,thefollowingguidelinesshouldbeobserved:
• Removalfollowsthereverseorderofimplantation
• Softtissueontheanteriorsurfaceoftheimplant shouldberemoved
• Assembletheimplantremoverbyplacingtheinnershaft intotheimplantremover
• Attachtheimplantremovertotheimplantbyturning theknobclockwisetothreadtheinnershaftintothe
centerfixationholeonthespacer.Theflatsonthe removeraretobeparalleltotheinferiorandsuperiorsurfacesoftheimplant.
• Removethescrewsusingascrewdriver
• Oncescrewsareremoved,removeimplantfromwound site.Theslottedmalletorslidehammerwithadaptercan
beusedtoaidinimplantremovalifnecessary.Ifusingtheslidehammer,threadtheadaptertothedistalendoftheslidehammer.Thenslidetheadapterovertheproximalendoftheremover.
22
Ordering Information
Solitaire™-C Small-Medium Lordotic Implant Kit
(Catalog No. 14-531504)
Catalog # Description Qty/Set
14-520506 6Hx14Wx12DLordoticSpacer 2
14-520507 7Hx14Wx12DLordoticSpacer 2
14-520508 8Hx14Wx12DLordoticSpacer 2
14-520509 9Hx14Wx12DLordoticSpacer 2
14-520510 10Hx14Wx12DLordoticSpacer 2
14-520536 6Hx16Wx14DLordoticSpacer 2
14-520537 7Hx16Wx14DLordoticSpacer 2
14-520538 8Hx16Wx14DLordoticSpacer 2
14-520539 9Hx16Wx14DLordoticSpacer 2
14-520540 10Hx16Wx14DLordoticSpacer 2
Solitaire™-C Small-Medium Parallel Implant Kit
(Catalog No. 14-531505)
Catalog # Description Qty/Set
14-520706 6Hx14Wx12DParallelSpacer 2
14-520707 7Hx14Wx12DParallelSpacer 2
14-520708 8Hx14Wx12DParallelSpacer 2
14-520709 9Hx14Wx12DParallelSpacer 2
14-520710 10Hx14Wx12DParallelSpacer 2
14-520736 6Hx16Wx14DParallelSpacer 2
14-520737 7Hx16Wx14DParallelSpacer 2
14-520738 8Hx16Wx14DParallelSpacer 2
14-520739 9Hx16Wx14DParallelSpacer 2
14-520740 10Hx16Wx14DParallelSpacer 2
23
Solitaire™-C Large Lordotic and Parallel Implant Kit
(Catalog No. 14-531506)
Catalog # Description Qty/Set
14-520586 6Hx18Wx15DLordoticSpacer 2
14-520587 7Hx18Wx15DLordoticSpacer 2
14-520588 8Hx18Wx15DLordoticSpacer 2
14-520589 9Hx18Wx15DLordoticSpacer 2
14-520590 10Hx18Wx15DLordoticSpacer 2
14-520786 6Hx18Wx15DParallelSpacer 2
14-520787 7Hx18Wx15DParallelSpacer 2
14-520788 8Hx18Wx15DParallelSpacer 2
14-520789 9Hx18Wx15DParallelSpacer 2
14-520790 10Hx18Wx15DParallelSpacer 2
Solitaire™-C Screws (Catalog No. 14-531500)
Included in Standard Instrument and Screw Kit
Catalog # Description Qty/Set
14-531712 3.5mmx12mmScrew 6
14-531714 3.5mmx14mmScrew 6
14-531715 3.5mmx15mmScrew 6
14-531722 3.75mmx12mmScrew 6
14-531724 3.75mmx14mmScrew 6
14-531725 3.75mmx15mmScrew 6
24
Ordering Information (Continued)
Solitaire™-C Standard Instrument and Screw Kit
(Catalog No. 14-531500)
Catalog # Description Qty/Set
14-520635 InserterHandle 2
14-531563 Mallet 1
14-531565 QuickConnectHandle 2
14-531593 Drill/AwlSleeve 2
14-531594 Spring-LoadedDrill/AwlSleeve 2
14-531602 12mmAwl** 2
14-531604 14mmAwl** 2
14-531605 15mmAwl** 2
14-531612 12mmDrill** 2
14-531614 14mmDrill** 2
14-531615 15mmDrill** 2
14-531571 DriverSleeve 2
14-531572 DriveSpringSleeve 2
14-531574 DriverforSleeves 2
14-531575 Auto-CenteringDriver 1
14-531576 Non-RetainingDriver 1
14-531577 ThreadedScrewInserter 1
14-531578 TipwithMalleableShaft 2
14-531579 ShortCenteringTip* 0
14-531581 FixedAngleDriver(45°) 2
14-531582 AngledDriverBit 2
14-531632 12mmAngledDrillBit** 2
14-531634 14mmAngledDrillBit** 2
14-531635 15mmAngledDrillBit** 2
14-531583 FixedAngledBitRemover 1
14-531702 12mmAngledAwl** 2
14-531585 FlexibleDriver 1
14-531586 Non-RetainingFlexibleDriver 1
14-531588 TorqueWrench 1
14-531590 ImplantRemover 1
14-531561 InnerShaft 1
14-531591 SlideHammer 1
14-531592 SlideHammerAdapter 1
14-531595 GraftPackingCaddy 1
*DenotesSpecialOrderItem
**DenotesSingleUseOnly
Solitaire™-C Standard Instrument and Screw Kit
(Catalog No. 14-531500) (Continued)
Catalog # Description Qty/Set
14-520636 14Wx6HSlimGuideTip 1
14-520637 14Wx7HSlimGuideTip 1
14-520638 14Wx8HSlimGuideTip 1
14-520639 14Wx9HSlimGuideTip 1
14-520640 14Wx10HSlimGuideTip 1
14-520646 16Wx6HSlimGuideTip 1
14-520647 16Wx7HSlimGuideTip 1
14-520648 16Wx8HSlimGuideTip 1
14-520649 16Wx9HSlimGuideTip 1
14-520650 16Wx10HSlimGuideTip 1
14-520651 18Wx6HSlimGuideTip 1
14-520652 18Wx7HSlimGuideTip 1
14-520653 18Wx8HSlimGuideTip 1
14-520654 18Wx9HSlimGuideTip 1
14-520655 18Wx10HSlimGuideTip 1
14-520666 14Wx6HOpenGuideTip 1
14-520667 14Wx7HOpenGuideTip 1
14-520668 14Wx8HOpenGuideTip 1
14-520669 14Wx9HOpenGuideTip 1
14-520670 14Wx10HOpenGuideTip 1
14-520676 16Wx6HOpenGuideTip 1
14-520677 16Wx7HOpenGuideTip 1
14-520678 16Wx8HOpenGuideTip 1
14-520679 16Wx9HOpenGuideTip 1
14-520680 16Wx10HOpenGuideTip 1
14-520681 18Wx6HOpenGuideTip 1
14-520682 18Wx7HOpenGuideTip 1
14-520683 18Wx8HOpenGuideTip 1
14-520684 18Wx9HOpenGuideTip 1
14-520685 18Wx10HOpenGuideTip 1
25
Solitaire™-C Small-Medium Lordotic Rasp and Trial Kit
(Catalog No. 14-531501)
Catalog # Description Qty/Set
14-531890 5/6Hx14Wx12DLordoticRasp(w/oStops) 1
14-531891 7/8Hx14Wx12DLordoticRasp(w/oStops) 1
14-531892 9/10Hx14Wx12DLordoticRasp(w/oStops) 1
14-531905 5/6Hx16Wx14DLordoticRasp(w/oStops) 1
14-531906 7/8Hx16Wx14DLordoticRasp(w/oStops) 1
14-531907 9/10Hx16Wx14DLordoticRasp(w/oStops) 1
14-531750 5/6Hx14Wx12DLordoticTrial(w/oStops) 1
14-531751 7/8Hx14Wx12DLordoticTrial(w/oStops) 1
14-531752 9/10Hx14Wx12DLordoticTrial(w/oStops) 1
14-531765 5/6Hx16Wx14DLordoticTrial(w/oStops) 1
14-531766 7/8Hx16Wx14DLordoticTrial(w/oStops) 1
14-531767 9/10Hx16Wx14DLordoticTrial(w/oStops) 1
14-531830 5/6Hx14Wx12DLordoticRasp(withStops) 1
14-531831 7/8Hx14Wx12DLordoticRasp(withStops) 1
14-531832 9/10Hx14Wx12DLordoticRasp(withStops) 1
14-531845 5/6Hx16Wx14DLordoticRasp(withStops) 1
14-531846 7/8Hx16Wx14DLordoticRasp(withStops) 1
14-531847 9/10Hx16Wx14DLordoticRasp(withStops) 1
14-531640 5/6Hx14Wx12DLordoticTrial(withStops) 1
14-531641 7/8Hx14Wx12DLordoticTrial(withStops) 1
14-531642 9/10Hx14Wx12DLordoticTrial(withStops) 1
14-531655 5/6Hx16Wx14DLordoticTrial(withStops) 1
14-531656 7/8Hx16Wx14DLordoticTrial(withStops) 1
14-531657 9/10Hx16Wx14DLordoticTrial(withStops) 1
26
Ordering Information (Continued)
Solitaire™-C Small-Medium Parallel Rasp and Trial Kit
(Catalog No. 14-531502)
Catalog # Description Qty/Set
14-532140 5/6Hx14Wx12DParallelRasp(w/oStops) 1
14-532141 7/8Hx14Wx12DParallelRasp(w/oStops) 1
14-532142 9/10Hx14Wx12DParallelRasp(w/oStops) 1
14-532155 5/6Hx16Wx14DParallelRasp(w/oStops) 1
14-532156 7/8Hx16Wx14DParallelRasp(w/oStops) 1
14-532157 9/10Hx16Wx14DParallelRasp(w/oStops) 1
14-532020 5/6Hx14Wx12DParallelTrial(w/oStops) 1
14-532021 7/8Hx14Wx12DParallelTrial(w/oStops) 1
14-532022 9/10Hx14Wx12DParallelTrial(w/oStops) 1
14-532035 5/6Hx16Wx14DParallelTrial(w/oStops) 1
14-532036 7/8Hx16Wx14DParallelTrial(w/oStops) 1
14-532037 9/10Hx16Wx14DParallelTrial(w/oStops) 1
14-532080 5/6Hx14Wx12DParallelRasp(withStops) 1
14-532081 7/8Hx14Wx12DParallelRasp(withStops) 1
14-532082 9/10Hx14Wx12DParallelRasp(withStops) 1
14-532095 5/6Hx16Wx14DParallelRasp(withStops) 1
14-532096 7/8Hx16Wx14DParallelRasp(withStops) 1
14-532097 9/10Hx16Wx14DParallelRasp(withStops) 1
14-531960 5/6Hx14Wx12DParallelTrial(withStops) 1
14-531961 7/8Hx14Wx12DParallelTrial(withStops) 1
14-531962 9/10Hx14Wx12DParallelTrial(withStops) 1
14-531975 5/6Hx16Wx14DParallelTrial(withStops) 1
14-531976 7/8Hx16Wx14DParallelTrial(withStops) 1
14-531977 9/10Hx16Wx14DParallelTrial(withStops) 1
27
Solitaire™-C Large Lordotic, Parallel Rasp and Trial Kit
(Catalog No. 14-531503)
Catalog # Description Qty/Set
14-531925 5/6Hx18Wx15DLordoticRasp(w/oStops) 1
14-531926 7/8Hx18Wx15DLordoticRasp(w/oStops) 1
14-531927 9/10Hx18Wx15DLordoticRasp(w/oStops) 1
14-531785 5/6Hx18Wx15DLordoticTrial(w/oStops) 1
14-531786 7/8Hx18Wx15DLordoticTrial(w/oStops) 1
14-531787 9/10Hx18Wx15DLordoticTrial(w/oStops) 1
14-531865 5/6Hx18Wx15DLordoticRasp(withStops) 1
14-531866 7/8Hx18Wx15DLordoticRasp(withStops) 1
14-531867 9/10Hx18Wx15DLordoticRasp(withStops) 1
14-531675 5/6Hx18Wx15DLordoticTrial(withStops) 1
14-531676 7/8Hx18Wx15DLordoticTrial(withStops) 1
14-531677 9/10Hx18Wx15DLordoticTrial(withStops) 1
14-532175 5/6Hx18Wx15DParallelRasp(w/oStops) 1
14-532176 7/8Hx18Wx15DParallelRasp(w/oStops) 1
14-532177 9/10Hx18Wx15DParallelRasp(w/oStops) 1
14-532055 5/6Hx18Wx15DParallelTrial(w/oStops) 1
14-532056 7/8Hx18Wx15DParallelTrial(w/oStops) 1
14-532057 9/10Hx18Wx15DParallelTrial(w/oStops) 1
14-532115 5/6Hx18Wx15DParallelRasp(withStops) 1
14-532116 7/8Hx18Wx15DParallelRasp(withStops) 1
14-532117 9/10Hx18Wx15DParallelRasp(withStops) 1
14-531995 5/6Hx18Wx15DParallelTrial(withStops) 1
14-531996 7/8Hx18Wx15DParallelTrial(withStops) 1
14-531997 9/10Hx18Wx15DParallelTrial(withStops) 1
28
Indications and Contraindications
Indications for Use
TheSolitaire™-CCervicalSpacerSystemisindicatedfor
stand-aloneanteriorcervicalinterbodyfusionprocedures
inskeletallymaturepatientswithcervicaldegenerativedisc
diseaseatonelevelfromC2toT1.Cervicaldegenerative
discdiseaseisdefinedasintractableradiculopathyand/or
myelopathywithherniateddiscand/orosteophyteformation
onposteriorvertebralendplatesproducingsymptomatic
nerverootand/orspinalcordcompressionconfirmedby
radiographicstudies.TheSolitaire™-CCervicalSpacerSystem
istobeusedwithautograftandimplantedviaananterior
approach.TheSolitaire™-CCervicalSpacermustbeimplanted
withtheSolitaire™-CTitaniumScrewsthatarepartofthe
system.Thiscervicaldeviceistobeusedinpatientswho
havehadsixweeksofnon-operativetreatment.
Contraindications
Contraindicationsinclude,butarenotlimitedto:
1. Infection,systemic,spinalorlocalized
2. Morbidobesity
3. Signsoflocalinflammation
4. Feverorleukocytosis
5. Metalsensitivity/allergiestotheimplantmaterials
6. anymedicalorsurgicalconditionwhichwouldpreclude
thepotentialbenefitofspinalimplantsurgery,suchas
theelevationofsedimentationrateunexplainedbyother
diseases,elevationofwhitebloodcount(WBC),ora
markedleftshiftintheWBCdifferentialcount
7. Grosslydistortedanatomydueto
congenitalabnormalities
8. Rapidjointdisease,boneabsorption,osteopenia,and/or
osteoporosis(osteoporosisisarelativecontraindication
sincethisconditionmaylimitthedegreeofobtainable
correction,theamountofmechanicalfixation,and/orthe
qualityofthebonegraft)
9. Anycasenotneedingabonegraftandfusionorwhere
fracturehealingisnotrequired
10. Anypatienthavinginadequatetissuecoverageoverthe
operativesite
11. Anypatientunwillingtocooperatewith
thepostoperativeinstructions
12.Priorfusionatthelevel(s)tobetreated.
Warnings
Thesurgeonshouldbeawareofthefollowing:
1. Thecorrectselectionoftheimplantisextremely
important.Thepotentialforsuccessisincreasedbythe
selectionofthepropersize,shapeanddesignofthe
implant.Thesizeandshapeofthehumanspinepresents
limitingrestrictionsofthesizeandstrengthofimplants.
2. Thesurgeonmustensurethatallnecessaryimplants
andinstrumentsareonhandpriortosurgery.Thedevice
mustbehandledandstoredcarefully,protectedfrom
damage,includingfromcorrosiveenvironments.They
shouldbecarefullyunpackedandinspectedfordamage
priortouse.
3. Allinstrumentsmustbecleanedandsterilizedprior
tosurgery.
4. Donotreuseimplants/devices.Whileanimplant/device
mayappearundamaged,previousstressmayhave
createdimperfectionsthatwouldreducetheservice
lifeoftheimplant/device.
5. Donottreatpatientswithimplants/devicesthathavebeen
evenmomentarilyplacedinorusedonadifferentpatient.
6. Properimplantselectionandpatientcomplianceto
postoperativeprecautionswillgreatlyaffectsurgical
outcomes.Patientswhosmokehavebeenshownto
haveanincreasedincidenceofnonunion.Therefore,
thesepatientsshouldbeadvisedofthisfactand
warnedofthepotentialconsequences.
29
7. Postoperativecareisimportant.Thepatientshouldbe
instructedinthelimitationsofhis/herimplantandshould
becautionedregardingweightbearingandbodystress
ontheappliancepriortosecurebonehealing.
8. Patientswithpreviousspinalsurgeryatthelevel(s)tobe
treatedmayhavedifferentclinicaloutcomescomparedto
thosewithoutaprevioussurgery.
9. TheSolitaire™-CSpacermustbeimplantedwiththe
Solitaire™-CTitaniumscrewsthatarepartofthesystem.
10. TheSolitaire™-CCervicalSpacerSystemhasnot
beenevaluatedforsafetyandCompatibilityinthe
MRenvironment.TheSolitaire™-CCervicalSpacer
Systemhasnotbeentestedforheatingormigration
intheMRenvironment.
Precautions
Preoperative:
1. Onlypatientsthatmeetthecriteriadescribedinthe
indicationsshouldbeselected.
2. Careshouldbeusedinthehandlingandstorageof
theimplantcomponents.Theimplantsshouldnot
bescratchedorotherwisedamaged.Implantsand
instrumentsshouldbeprotectedduringstorage
especiallyfromcorrosiveenvironments.
3. BiometSpineimplantsshouldnotbeusedwithimplants
orinstrumentsfromanothermanufacturerforreasonsof
metallurgy,mechanicsanddesign.
Intraoperative:
1. Anyinstructionmanualsshouldbecarefullyfollowed.
2. Atalltimes,extremecautionshouldbeusedaroundthe
spinalcordandnerveroots.Damagetonervesmayoccur
resultinginalossofneurologicalfunctions.Bonegrafts
mustbeplacedintheareatobefused.
Postoperative:
1. Thephysician’spostoperativedirectionsandwarningsto
thepatientandthecorrespondingpatientcomplianceare
extremelyimportant.
2. Detailedinstructionsontheuseandlimitationsof
thedeviceshouldbegiventothepatient.Ifpartial
weight-bearingisrecommendedorrequiredprior
tofirmbonyunion,thepatientmustbewarnedthat
bending,looseningorbreakageofthecomponentsare
complicationswhichcanoccurasaresultofexcessive
orearlyweight-bearingorexcessivemuscularactivity.
Theriskofbending,loosening,orbreakageofaninternal
fixationdeviceduringpostoperativerehabilitationmay
beincreasedifthepatientisactive,orifthepatient
isdebilitated,demented,orotherwiseunabletouse
crutchesorothersuchweightsupportingdevices.The
patientshouldbewarnedtoavoidfallsorsuddenjoltsin
spinalposition.
3. Toallowmaximumchancesforasuccessfulsurgical
result,thepatientordeviceshouldnotbeexposed
tomechanicalvibrationsthatmayloosenthedevice
construct.Thepatientshouldbewarnedofthispossibility
andinstructedtolimitandrestrictphysicalactivities,
especiallylifting,twistingmotionsandanytypeofsport
participation.Thepatientshouldbeadvisednotto
smokeorconsumealcoholduringthebonegraft
healingprocess.
4. Ifanonuniondevelopsorifthecomponentsloosen,
bend,and/orbreak,thedevice(s)shouldberevisedand/
orremovedimmediatelybeforeseriousinjuryoccurs.
Failuretoimmobilizeadelayedornonunionofbonecan
resultinexcessiveandrepeatedstressesontheimplant.
Bythemechanismoffatiguethesestressescancause
eventualbending,loosening,orbreakageofthedevice(s).
Itisimportantthatimmobilizationofthespinalsurgical
sitebemaintaineduntilfirmbonyunionisestablished
andconfirmedbyradiographicexamination.Thepatient
mustbeadequatelywarnedofthesehazardsandclosely
supervisedtoensurecooperationuntilbonyunion
isconfirmed.
30
Indications and Contraindications (Continued)
5. Anyretrieveddevicesshouldbetreatedinsuchamanner
thatreuseinanothersurgicalprocedureisnotpossible.
Aswithallorthopaedicimplants,noneoftheSolitaire-C
CervicalSpacerSystemcomponentsshouldeverbe
reusedunderanycircumstances.
Potential Adverse Effects and Complications
Possibleadverseeffectsinclude,butarenotlimitedto:
1. Bending,loosening,migrationorfractureoftheimplants
orinstruments
2. Lossoffixation
3. Sensitivitytoametallicforeignbody,includingpossible
tumorformation
4. Skinormusclesensitivityinpatientswithinadequate
tissuecoverageovertheoperativesite,whichmayresult
inskinbreakdownand/orwoundcomplications
5. Nonunionordelayedunion
6. Infection
7. Nerveorvasculardamageduetosurgicaltrauma,
includinglossofneurologicalfunction,duraltears,
radiculopathy,paralysisandcerebralspinalfluidleakage
8. Gastrointestinal,urologicaland/orreproductivesystem
compromise,includingsterility,impotencyand/orlossof
consortium
9. Painordiscomfortattheoperativeand/orbonegraft
donorsite
10. Bonelossduetoresorptionorstressshielding,orbone
fractureat,aboveorbelowthelevelorsurgery(fracture
ofthevertebra)
11.Hemorrhageofbloodvesselsand/orhematomas
12.Misalignmentofanatomicalstructures,including
lossofproperspinalcurvature,correction,reduction
and/orheight
13.Bursitis
14.Inabilitytoresumeactivitiesofnormaldailyliving
15.Reoperation
16.Death
Sterilization
Unlesssuppliedsterile,devicesmustbesterilizedprior
tosurgicaluse.Productprovidedsterileissterilizedby
exposuretoaminimumdoseof2.5Megarads(25kGy)
gammaradiation.Wherespecified,donotuseimplantsafter
expirationdate.Re-sterilizationisnotrecommended.
Forproductsuppliednon-sterile,allpackagingmaterials
mustberemovedpriortosterilization.Thefollowingsteam
sterilizationparametersarerecommended:
U.S.SterilizationParameters:
Cycle:Pre-vacuumSteam
Temperature:270°F/132°C
Time:4minutes
DryingTime:30minutes
NOTE:Allowforcooling
FDAclearedsterilizationwrapsshouldbeusedtomaintain
sterilityafterprocessing.
SterilizationParametersforUseOutsideofU.S.:
Cycle:Pre-vacuumSteam
Temperature:275°F/135°C
Time:3minutes
DryingTime:30minutes
NOTE:Allowforcooling
31
Further Information
Biometdoesnotrecommendstackingoftraysduringthe
sterilizationprocess.
Individualsorhospitalsnotusingtherecommendedmethod,
temperature,andtimeareadvisedtovalidateanyalternative
methodsorcyclesusinganapprovedmethodorstandard.
Additionalinformationaboutinstrumentation(including
assembly/disassembly)maybefoundinthesystemsurgical
technique,referenceguideand/orassociatedpackageinserts.
RefertotheBiometNon-sterileInstrumentIFUforfull
processinginstructionsforinstruments.
Forfurtherinformation,pleasecontacttheCustomer
ServiceDepartmentat:
BiometSpine
310InterlockenParkway,Suite120,
Broomfield,CO80021
303.443.7500•800.447.3625
biometspine.com
32
Notes:
C
Broomfield,CO•800.447.3625biometspine.com•BSP231088L04/14
©2014BiometSpine,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated.PEEK-OPTIMA®isaregisteredtrademarkofInvibio®Limited.RxOnly.
AtBiomet,engineeringexcellenceisourheritageand
ourpassion.Forover25years,throughvarious
divisionsworldwide,wehaveappliedthemost
advancedengineeringandmanufacturingtechnology
tothedevelopmentofhighlydurablesystemsfora
widevarietyofsurgicalapplications.
Tolearnmoreaboutthisproduct,
contactyourlocalBiometSalesRepresentativetoday.
Solitaire™-C Cervical Spacer SystemA Zero Profile Anterior Fusion Cervical Device