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
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+2K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+2K153603Alphatec Navigation InstrumentsAlphatec Spine, Inc.201679—
+2K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.201587—
+2K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+2K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc.2015207—
+2K143628Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015206—
+3K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K260477CATAMARAN™ SI Joint Fusion SystemTenon Medical20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K252989“POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories SetPoint Robotics MedTech, Inc.20260—
+3K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+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—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K250403Catamaran SI Joint Fusion SystemTenon Medical20251—
+3K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K241895Cannulated PsiFGuardSpineguard20240—
+3K241813SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC20241—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+3K240963Spinal SystemTeslake, Inc.20240—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+3K232149BowTie™ SI Joint Fusion SystemSail Fusion, LLC20242—
+3K232259Patriot-SI Posterior Implant SystemSpinal Simplicity, LLC20241—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+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—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+3K233241SOLACE Sacroiliac Fixation SystemHt Medical, LLC Dba Xenix Medical20231—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+3K230857TiLink-P SI Joint Fusion SystemSurGenTec, LLC20234—
+3K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.20234—
+3K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc.20230—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K231184CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+3K220274Kisar Stratford SI Screw SystemAnjali Investments L.L.C20230—
+3K213815SiJoin®T3Vgi Medical, Inc.20230—
+3K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+3K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+3K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+3K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K213918DeGen Navigated InstrumentationDegen Medical20220—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K210402Curiteva Sacroiliac Joint Fusion SystemCuriteva, Inc.20212—
+3K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.202115—
+3K211596CD Horizon Spinal SystemMedtronic20213—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K210472SPINEART Navigation Instrument SystemSpineart20215—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+3K202771CD Horizon Spinal SystemMedtronic202021—
+3K201006K2M Navigation InstrumentsK2m, Inc.20200—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—