510(k) Report

Devices descending from K003780

420 later devices reach Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K193129Yukon OCT Spinal SystemK2m, Inc.202001
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173047The Solstice OCT SystemLife Spine, Inc.20180—
+3K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K162575Z-LINKPC SystemZavation, LLC20173—
+3K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+3K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+3K161149PASS OCT Spinal SystemMedicrea International SA20160—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K160756PASS OCT Spinal SystemMedicrea International SA20160—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K153169PASS OCT Patient Specific RodsMedicrea International20164—
+3K142253SOLSTICE OCT SystemLife Spine, Inc.20153—
+3K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m20140—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K141284Caspian Spinal SystemK2m, Inc.20140—
+3K133288Caspian Oct Spinal SystemK2m, Inc.201418—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131833Centurion Poct SystemOrthofix, Inc.20142—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K123906Vertex Reconstruction System, Vertext Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201322—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123568Vertex Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20120—
+3K121725Pioneer Posterior Occipito-Cervico-Thoracic (Oct) SystemPioneer Surgical Technology, Inc.201217—
+3K120998Solstice Cross ConnectorLife Spine20121—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K113654CaspianK2m, Inc.201244—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+3K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+3K103232Caspian Spinal SystemK2m, Inc.201146—
+3K100888Modification to Lanx Posterior Cervicothoracic Spinal Fixation SystemLanx, Inc.20103—
+3K100191Lanx Posterior Cervicothoracic Spinal Fixation System (PCFS)Lanx, Inc.20103—
+3K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138—
+3K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+3K071942Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek200724—
+3K062447Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2007107—
+3K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+3K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006151—
+3K060683Endius Minit Posterior Cervical and Upper Thoracic Fixation SystemEndius, Inc.200632—
+3K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+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—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232167VySpan™ PCT SystemVy Spine, LLC20230—
+4K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+4K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+4K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K201569CUVIS-spineCurexo, Inc.20212—
+4K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+4K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+4K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+4K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+4K200896Solstice CCILife Spine, Inc.20200—
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+4K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+4K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—