510(k) Report

Devices descending from K143471

165 later devices reach VERTEX Reconstruction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K171250BRIDALVEIL Occipital Cervical Thoracic SystemAstura Medical20171—
+1K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+1K172139Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20170—
+1K161637Poseidon OCT Spinal Fixation SystemMedyssey USA, Inc.20170—
+1K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20161—
+1K153439PathLoc-C Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20160—
+1K161149PASS OCT Spinal SystemMedicrea International SA20160—
+1K160756PASS OCT Spinal SystemMedicrea International SA20160—
+1K153386Perla Posterior Cervico-Thoracic Fixation systemSpineart20162—
+1K152338VERTEX (r) Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201534—
+1K150474NuVasive VuePoint II OCT SystemNu Vasive, Incorporated201526—
+1K150918PASS OCT Spinal SystemMedicrea International SA201513—
+1K151705Lotus Posterior Cervical/Thoracic Spinal SystemSpinal Elements, Inc.20150—
+1K151031Virage OCT Spinal Fixation SystemZimmer Spine, Inc.201520—
+1K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+1K150570ANAX OCT Spinal SystemU&I Corporation20152—
+1K150539OASYS SystemStryker Corporation201534—
+2K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+2K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250—
+2K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+2K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+2K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+2K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+2K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+2K190071Perla® Posterior Cervico-Thoracic Fixation SystemSpineart20191—
+2K183383ANAX™ OCT Spinal SystemU&I Corporation20181—
+2K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+2K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+2K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+2K173522Solanas® Posterior Stabilization SystemAlphatec Spine, Inc.20175—
+2K172279PMT Posterior Fixation SystemProvidence Medical Technology, Inc.20170—
+2K162300Reform® POCT SystemPrecision Spine, Inc.20162—
+2K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+2K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+2K153631Zimmer Virage OCT Spinal Fixation SystemZimmer Spine, Inc.201618—
+2K153169PASS OCT Patient Specific RodsMedicrea International20164—
+2K153336VuePoint OCT SystemNu Vasive, Incorporated20162—
+2K151755OASYS (r) SystemStryker Corporation201533—
+3K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+3K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+3K250332Virage® OCT Spinal Fixation SystemHighridge Medical, LLC20250—
+3K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+3K220132FIREFLY® Cervical Navigation GuideMighty Oak Medical, Inc.20221—
+3K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+3K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+3K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+3K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+3K201481Centurion POCT SystemOrthofix, Inc.20203—
+3K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+3K200863Tiger® Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20200—
+3K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+3K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+3K191185Solanas® Posterior OCT Fixation SystemAlphatec Spine20194—
+3K182182YUKON OCT Spinal SystemK2m20185—
+3K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+3K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+3K172495Reform® POCT SystemPrecision Spine, Inc.20181—
+3K171834G Surgical OCT Spinal SystemG Surgical, LLC20170—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+3K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+3K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+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—
+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—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231515MySpine Cervical GuidesMedacta International S.A.20230—
+4K233366SYMPHONY OCT SystemMedos International SARL20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+4K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—