510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+9K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+9K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+9K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+9K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+9K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+9K181014Tritanium PL CageStryker Spine2018137—
+9K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+9K181188EVEREST Spinal SystemK2m, Inc.20186—
+9K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+9K171321K2M Navigation InstrumentsK2m201711
+9K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+9K160715AccuLIF TL and PL CageStryker Corporation20160—
+9K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+9K153629ArcadiusXP C Spinal SystemAesculap Implant Systems, Inc.20167—
+9K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+9K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+9K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+9K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K151785Px HA PEEK IBF SystemInnovasis, Inc.201557—
+9K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+9K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+9K141187Impix Alif S/aMedicrea International SA201501
+9K141135Juliet LLSpineart2014146—
+9K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+9K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+9K141217Acculif TL and PL CageStryker Corporation20146423
+9K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+9K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+9K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+9K130641Logic Stand-Alone Intervertebral Body Fusion DeviceBinder Biomedical, Inc.20130—
+9K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG20130—
+9K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+9K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+9K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+9K120869Anchor-L Lumbar CageStryker Spine2012638—
+9K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+9K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+9K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+9K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+9K121116Plateau Spacer SystemLife Spine201213—
+9K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+9K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+9K110063Sovereign Spinal SystemMedtronic Sofamor Danek, Inc.2011718—
+9K111626Endoskeleton (R) TasTitan Spine, LLC2011273—
+9K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+9K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+9K103369Vault Alif SystemSpinal USA201110—
+9K101301Stalif MidlineCentinel Spine2010474—
+9K083475Lucent MagnumSpinal Elements, Inc.2009834—
+9K081711Lucent Magnum+Spinal Elements, Inc.20080—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+10K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+10K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+10K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206—
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+10K182721Choice Spine Navigation SystemChoicespine, LP20192—
+10K180437Hexanium® TLIFSpinevision, S.A.S.20182—
+10K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+10K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+10K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+10K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+10K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+10K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+10K130445Vault Alif SystemSpinal USA20139—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+11K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+11K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+11K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+11K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+11K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+11K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+11K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+11K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+11K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+11K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+11K230989Rod Registration FrameNu Vasive, Incorporated20230—