510(k) Report

Devices descending from K042524

373 later devices reach Modification to Vertex Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062934SierraSeaspine, Inc.200621—
+1K052376Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005254—
+1K050979S4 Spinal SystemAesculap, Inc.200567—
+1K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148—
+2K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+2K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+2K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+2K133214Blackbird Spinal SystemChoicespine, LP20143—
+2K133698Synapse SystemSynthes USA Products, LLC20146—
+2K132900Marauder Cervical-Thoracic Spinal Fixation SystemIntelligent Implant Systems, LLC20130—
+2K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+2K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122—
+2K121136Renoir Posterior Cervial Fixation SystemAccel Spine20120—
+2K120467Spinal Elements Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20121—
+2K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd.201215—
+2K103414Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd.201116—
+2K110197Exactech Gibralt Spinal SystemExactech, Inc.2011151
+2K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+2K101084Caspian Spinal SystemK2m, Inc.201062—
+2K090565Ellipse Occipito-Cerico-Thoracic Spinal SystemGlobus Medical, Inc.2009101—
+2K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek2009233—
+2K081906Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2008104—
+2K072729SierraSeaspine, Inc.20085—
+2K080526Sierra SystemSeaspine, Inc.20089—
+2K062327Modification to S4 Spinal SystemAesculap, Inc.200714—
+2K060152Modification to S4 Spinal SystemAesculap, Inc.200632—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+3K231654NorthStar OCT SystemSeaspine, Inc.20230—
+3K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.202011—
+3K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+3K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+3K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+3K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+3K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+3K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+3K160428Certex Spinal Fixation SystemX-Spine Systems, Inc.20160—
+3K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+3K152211PCT SystemCentinel Spine, Inc.20150—
+3K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201513—
+3K143249SOLSTICE OCT SystemLife Spine, Inc.20151—
+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—
+3K140645Gibralt Rod-to-Rod Cross ConnectorsExactech Sarasota20141—
+3K133374Streamline Oct Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.20131—
+3K131427LOTUSSpinal Elements, Inc.20130—
+3K130887S4C Navigation InstrumentsAesculap Implant System, Inc.201313—
+3K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+3K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134—
+3K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc.201223—
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102—
+3K113654CaspianK2m, Inc.201244—
+3K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA20114—
+3K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128—
+3K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+3K103232Caspian Spinal SystemK2m, Inc.201146—
+3K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+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—
+4K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+4K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+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—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—