510(k) Report

Devices descending from K060361

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+4K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+4K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+4K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K252322SIros-X SystemGenesys Spine20250—
+5K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+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—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+5K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K240160EGPS Navigated InstrumentsAstura Medical20240—
+5K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+5K231479TriALTIS Spine SystemMedos International SARL20238—
+5K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+5K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+5K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+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—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+5K171582NEO Pedicle Screw System™Neo Medical SA20170—
+5K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+5K171881JAZZ Passer BandImplanet, S.A.20170—