510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+10K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+10K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+10K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+10K151312VerteLP Interbody Fusion DeviceVgi, LLC201601
+10K152651AccuLIF TL and PL CageStryker Corporation201530—
+10K152355Twin Peaks Lumbar Interbody Fusion SystemSpineway20151—
+10K152304Tritanium PL CageStryker20154481
+10K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+10K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+10K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+10K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+10K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+10K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+10K130445Vault Alif SystemSpinal USA20139—
+10K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+10K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+10K111835Plateau Spacer SystemLife Spine, Inc.2011120—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+11K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+11K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+11K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+11K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+11K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+11K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+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—
+11K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+11K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+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—
+11K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+11K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+11K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+11K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+11K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+11K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+11K221244CD Horizon™ Spinal SystemMedtronic202220—
+11K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+11K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+11K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+11K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+11K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+11K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+11K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+11K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+11K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+11K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+11K201006K2M Navigation InstrumentsK2m, Inc.20200—
+11K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+11K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+11K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+11K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+11K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+11K173518Spectrum Spine Expandable Cages (SSEC)Spectrum Spine, LLC20196—
+11K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+11K181963ostaPek Interbody Fusion CagesColigne AG20181—
+11K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+11K181792Duo™ Lumbar Interbody Fusion DeviceSpineology, Inc.20183—
+11K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+11K172115Navigated Instrument SystemOrthofix, Inc.20184—
+11K171425Concorde LiftMedos International SARL201782
+11K162921Navigated Instrument SystemOrthofix, Inc.20175—
+11K163180Hubble IIOrbbo Surgical, LLC20160—
+11K162262Tritanium® PL CageStryker2016132—
+11K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+11K160955Tritanium® PL CageStryker2016178—
+11K160715AccuLIF TL and PL CageStryker Corporation20160—
+11K153400ProLift Expandable SystemLife Spine, Inc.201672—
+11K133813Flxfit Intervertebral Body Fusion DeviceExpanding Orthopedics, Inc.2014137—
+11K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+11K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+11K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+11K130194Acculif XL CageCoalign Innovations, Inc.20131—
+12K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+12K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+12K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+12K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+12K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+12K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+12K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+12K241895Cannulated PsiFGuardSpineguard20240—
+12K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+12K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+12K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+12K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+12K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+12K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+12K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+12K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+12K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—