510(k) Report

Devices descending from K143628

206 later devices reach Navigated Vertex Select Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC20260—
+1K252087Navigation Module of the Cortium® SystemUlrich Medical USA, Inc.20260—
+1K230369EUROPA™ Navigated InstrumentsMiRus, LLC20230—
+1K223200Curiteva Navigation SystemCuriteva, Inc.20230—
+1K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+1K212007VERTICALE Navigation InstrumentsSilony Medical GmbH20214—
+1K203573RESPONSE Navigation InstrumentsOrthoPediatrics Corp.20210—
+1K190881Spinal Elements Navigated InstrumentsSpinal Elements, Inc.20194—
+1K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+1K183381Navigation Enabled InstrumentsStryker20191—
+1K182982BridalVeil Navigated InstrumentsAstura Medical20190—
+1K181596Spine Wave Navigated InstrumentsSpine Wave, Inc.20181—
+1K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+1K181111Navigated INFINITY InstrumentsMedtronic Sofamor Danek USA, Inc.20182—
+1K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+1K172166OLYMPIC Navigated InstrumentsAstura Medical20185—
+1K173338Navigated INFINITY™ InstrumentsMedtronic Sofamor Danek USA, Inc.201815—
+1K171321K2M Navigation InstrumentsK2m201711
+1K160713Stealth-Midas SystemMedtronic Powered Surgical Solutions20169—
+1K153203Navigation InstrumentsGlobus Medical, Inc.2016112—
+2K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—
+2K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+2K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+2K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+2K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+2K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+2K223649VERTICALE® Navigation InstrumentsSilony Medical GmbH20223—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K220241“POINT” Kinguide Robotic-Assisted Surgical SystemPoint Robotics MedTech, Inc.20224—
+2K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+2K212023Virage Navigation SystemZimmer Biomet Spine, Inc.20211—
+2K203816DeGen Navigated InstrumentationDegen Medical20211—
+2K210472SPINEART Navigation Instrument SystemSpineart20215—
+2K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+2K201006K2M Navigation InstrumentsK2m, Inc.20200—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K200791Navigation Enabled IntrumentsMedos International SARL20205—
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+2K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+2K192526Spine Wave Navigated InstrumentsSpine Wave, Inc.20190—
+2K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+2K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions20193—
+2K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+2K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+2K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+2K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K250167Evolution Spine Navigation InstrumentsEvolution Spine20250—
+3K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K233255CROSSNAV Navigation Enabled InstrumentsDePuy Synthes20242—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K240647Virage® Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+3K231527TriALTIS Navigation Enabled InstrumentsMedos International Sàrl20233—
+3K230087“POINT” Kinguide Agile Hybrid Navigation SystemPoint Robotics MedTech, Inc.20233—
+3K230861VADER® Pedicle System Navigated InstrumentsIcotec AG20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+3K213918DeGen Navigated InstrumentationDegen Medical20220—
+3K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+3K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+3K202552Midas Rex Attachments and Dissecting ToolsMedtronic Powered Surgical Solutions (Mpss)20200—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K182345Spineology Navigation InstrumentsSpineology, Inc.20182—
+3K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+3K180796Spineology Navigation InstrumentsSpineology, Inc.20183—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—