510(k) Report

Devices descending from K140454

396 later devices reach Navigated CD Horizon Solera Screwdriver/Taps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K213918DeGen Navigated InstrumentationDegen Medical20220—
+2K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+2K212903SIMPACT Sacroiliac Joint Fixation SystemLife Spine, Inc.20218—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC20210—
+2K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+2K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+2K211596CD Horizon Spinal SystemMedtronic20213—
+2K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K210472SPINEART Navigation Instrument SystemSpineart20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+2K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+2K202771CD Horizon Spinal SystemMedtronic202021—
+2K201006K2M Navigation InstrumentsK2m, Inc.20200—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+2K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K191748Genesys Spine Sacroiliac Joint Fusion SystemGenesys Spine201922—
+2K191148Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.201950—
+2K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+2K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182721Choice Spine Navigation SystemChoicespine, LP20192—
+2K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+2K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+2K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+2K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K171321K2M Navigation InstrumentsK2m201711
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+2K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+2K152248CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.20150—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+3K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+3K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K252742Navigated InstrumentsTyber Medical, LLC20251—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+3K252437JAZZ Spinal SystemImplanet20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+3K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+3K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K241895Cannulated PsiFGuardSpineguard20240—
+3K241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysMedos International SARL20241—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240392JAZZ Spinal SystemImplanet20241—
+3K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+3K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+3K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K213815SiJoin®T3Vgi Medical, Inc.20230—
+3K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K223181NuVasive Reline SystemNu Vasive, Incorporated202311—