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
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K203503Camber Sacroiliac (SI) Fixation SystemCamber Spine Technologies, LLC20222—
+3K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+3K211496TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20227—
+3K220131KYPHON VuE Bone CementTecres S.P.A.20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K220724CD Horizon™ Spinal System and PASS LP™ Spinal SystemMedicrea International20221—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+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—
+3K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.20211—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+3K203247iFuse-TORQ™ Implant SystemSI-BONE, Inc.2021171
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K193011CD Horizon™ Fenestrated Screw SetMedtronic Sofamor Danek USA, Inc.202041—
+3K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+4K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+4K261374LigaPASS™ SystemMedicrea International S.A.S20260—
+4K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+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—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K241504iFuse TORQ TNT™ Implant SystemSI-BONE, Inc.20240—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC20243—
+4K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232878TransLoc 3DFoundation Fusion Solutions, LLC (Dba Cornerloc)20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+4K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+4K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+4K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+4K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+4K231689iFuse TORQ® Implant SystemSI-BONE, Inc.20235—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K222605iFuse TORQ® Implant SystemSI-BONE, Inc.202214—
+4K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+4K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K213876Spineology Navigation InstrumentsSpineology, Inc.20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K213667iFuse-TORQ® Implant SystemSI-BONE, Inc.202215—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—