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
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+3K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+3K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253331PressON Spinal Fixation SystemNexus Spine20250—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC20251—
+4K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20250—
+4K250001Patriot SI Implant SystemSpinal Simplicity, LLC20250—
+4K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241846E3D™-C Interbody SystemEvolution Spine20246—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K242414TiLink-P Joint Fusion SystemSurGenTec, LLC20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K242141TiLink-P SI Joint Fusion SystemSurGenTec, LLC20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—