510(k) Report

Devices descending from K124004

404 later devices reach Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+1K242806Medyssey Navigation SystemMedyssey Co, Ltd.20250—
+1K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+1K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+1K200845Navigation Module of the Momentum SystemUlrich Medical USA20200—
+1K201362CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic202038—
+1K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+1K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+1K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+1K171267NavLock TrackersMedtronic Navigation201741
+1K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek201786—
+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—
+1K140454Navigated CD Horizon Solera Screwdriver/TapsMedtronic Sofamor Danek USA, Inc.20143961
+1K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+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—
+2K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+2K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+2K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+2K252322SIros-X SystemGenesys Spine20250—
+2K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+2K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+2K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+2K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+2K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+2K250182Innovasis Navigation InstrumentsInnovasis, Inc.202521
+2K243073AnyPlus Navigated Instruments SystemGS Medical Co., Ltd.20240—
+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—
+2K232211REUNION Sacroiliac Joint Fusion SystemAstura Medical20231—
+2K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+2K231829Xenix Medical Sacroiliac Fixation SystemHt Medical D.B.A. Xenix Medical20232—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+2K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+2K223511Excella Navigation InstrumentsInnovasis, Inc.20233—
+2K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+2K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+2K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+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—
+2K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC20220—
+2K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+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—
+2K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+2K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K210637CD Horizon™ Spinal SystemMedtronic202134—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K203816DeGen Navigated InstrumentationDegen Medical20211—
+2K203780Harvester SI: Sacroiliac Fixation SystemSpinus International, Inc.20210—
+2K202956Erisma LP Navigated InstrumentsClariance, Sas20210—
+2K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+2K203291CD Horizon Spinal System InstrumentsMedtronic Sofamor Danek USA, Inc.202035—
+2K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.202054—
+2K190580NADIA SI Fusion SystemIlion Medical, Inc.20203—
+2K200791Navigation Enabled IntrumentsMedos International SARL20205—
+2K200095Streamline Navigated InstrumentsPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.202004
+2K201327NavLock TrackersMedtronic Navigation20202—
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+2K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+2K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+2K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+2K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+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—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K183381Navigation Enabled InstrumentsStryker20191—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+2K182121CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.201841—
+2K182104NavLock Trackers, Robotic Reference FrameMedtronic Navigation201831
+2K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)Tenon Medical, Inc.201830—
+2K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—