510(k) Report

Devices descending from K050461

742 later devices reach Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+7K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+7K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+7K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+7K191575ARx Spinal SystemLife Spine, Inc.201910—
+7K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+7K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+7K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+7K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+7K171881JAZZ Passer BandImplanet, S.A.20170—
+7K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+7K171838TiLock2 Spinal SystemGenesys Spine20174—
+7K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+7K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+7K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+7K170647Connector SystemOrthofix, Inc.201718—
+7K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+7K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K161842Overwatch Spine SystemAmendia, Inc.201661
+7K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+7K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151974Polaris Spinal SystemBiomet Spine201516—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+7K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+7K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+7K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+7K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+7K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+7K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+7K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+7K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+7K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+7K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+7K120838Synthes Matrix SystemSynthes Spine201216—
+7K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+7K120571Synthes Uss ConnectorSynthes Spine201274—
+7K113058Tiger Spine SystemCorelink, LLC201281—
+8K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+8K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+8K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+8K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+8K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+8K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+8K240392JAZZ Spinal SystemImplanet20241—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K231515MySpine Cervical GuidesMedacta International S.A.20230—
+8K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+8K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+8K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—