510(k) Report

Devices descending from K150231

242 later devices reach Navigated Disc Prep Instruments and CAPSTONE Trials through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+1K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+1K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+1K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+1K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+1K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+1K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+1K182721Choice Spine Navigation SystemChoicespine, LP20192—
+1K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+1K161210RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM)…Medtronic Sofamor Danek201679—
+1K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+2K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+2K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+2K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K252742Navigated InstrumentsTyber Medical, LLC20251—
+2K252322SIros-X SystemGenesys Spine20250—
+2K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+2K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+2K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+2K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233595Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine20241—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K233972Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies20241—
+2K232800Navigation Tracking InstrumentsSI-BONE, Inc.20240—
+2K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+2K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+2K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K221047SILO TFX MIS Sacroiliac Joint Fixation SystemAurora Spine, Inc.20229—
+2K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+2K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241895Cannulated PsiFGuardSpineguard20240—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+3K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+3K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K213815SiJoin®T3Vgi Medical, Inc.20230—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—