510(k) Report

Devices descending from K023555

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121630Range Spinal SystemK2m, Inc.2012127—
+4K113654CaspianK2m, Inc.201244—
+4K111076Solanas Avalon Posterior Fixation SystemAlphatec Spine, Inc.20115—
+4K103232Caspian Spinal SystemK2m, Inc.201146—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+5K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K200571PERLA® Posterior Occipito-Cervico-Thoracic Fixation SystemSpineart20200—
+5K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K181890Brainlab Compatible K2M Navigation InstrumentsK2m201811—
+5K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+5K162575Z-LINKPC SystemZavation, LLC20173—
+5K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+5K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.201612—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K153700Aesculap (R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC20160—
+5K151974Polaris Spinal SystemBiomet Spine201516—
+5K150918PASS OCT Spinal SystemMedicrea International SA201513—
+5K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+5K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+5K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)201523
+5K150229SOLSTICE OCT SystemLife Spine, Inc.20150—
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K141147Range Spinal SystemK2m, Inc.20141—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132504Tiger Occipital-Cervical-Thoracic Spinal Fixation SystemCorelink, LLC20132—
+5K132757Everest Spinal SystemK2m, Inc.201341—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+5K121808Casian, 3.5/4.5 ConnectorsK2m, Inc.20121—
+5K120656Everest Spinal SystemK2m, Inc.201243—
+6K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+6K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+6K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+6K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—