510(k) Report

Devices descending from K984251

372 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+1K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+1K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+1K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+1K071074Mykres Spinal SystemShowa Ika Kohgyo Co., Ltd.20080—
+1K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+1K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+1K071438PSS SystemSpinal USA200739—
+1K062785LTD Polyaxial Fixation SystemUs Spine200641—
+1K061813Mantis Spinal SystemStryker Spine20061352
+1K020293Osteonics Spinal SystemHowmedica Osteonics Corp.20020—
+1K013688Modification to Xia Spinal SystemHowmedica Osteonics Corp.2001205—
+1K012027Modification to Xia Spine SystemHowmedica Osteonics2001206—
+1K001080Spine System EvolutionAesculap, Inc.200062—
+2K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+2K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+2K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+2K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+2K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+2K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+2K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+2K171651Excelsius GPSGlobus Medical, Inc.2017691
+2K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+2K153152Syzygy Stabilization SystemAmendia, Inc.201602
+2K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+2K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+2K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+2K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+2K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+2K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+2K131343Reform Pedicle Screw SystemSpinal USA201331—
+2K130279Reform Pedicle Screw SystemSpinal USA201331—
+2K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+2K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+2K122931S-Lok PSS SystemSpinal USA20120—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K121172Reform Pedicle Screw SystemSpinal USA201233—
+2K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+2K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+2K092631Mantis Redux Spinal SystemStryker Spine2009110—
+2K092128Modification to: PSS SystemSpinal USA200936—
+2K090033Modification to: PSS SystemSpinal USA200937—
+2K081296Preference Pedicle Screw SystemUs Spine20083—
+2K073240PSS SystemSpinal USA200836—
+2K073151Mantis Spinal SystemStryker Corp.2007111—
+2K062912Scient'x Spinal SystemScient'X200736—
+2K052181Modification to Xia Spinal SystemStryker Spine2005202—
+2K014229Modification to Opus Spinal SystemHowmedica Osteonics Corp.20021—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+3K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+3K240160EGPS Navigated InstrumentsAstura Medical20240—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K223558CUVIS-spineCurexo, Inc.20230—
+3K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+3K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220025ARx® Spinal SystemLife Spine, Inc.20220—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K201569CUVIS-spineCurexo, Inc.20212—
+3K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+3K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+3K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K200303Reform Pedicle Screw SystemPrecision Spine202010—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+3K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—