510(k) Report

Devices descending from K012870

908 later devices reach Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K150449LITe Plate SystemStryker Corp.201524—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A.20143—
+3K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC201410—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K131533Cayman MI Plate SystemK2m, Inc.201372—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+3K123717UcentumUlrich GmbH & Co. KG2013171
+3K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K111729Pilot Spinal SystemLife Spine, Inc.201113—
+3K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+3K103671Genesys Spine Tilock SystemGenesys Spine20118—
+3K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+3K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+3K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+3K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+3K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K082617Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd.20098—
+3K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K073151Mantis Spinal SystemStryker Corp.2007111—
+3K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20074301
+3K061813Mantis Spinal SystemStryker Spine20061352
+3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+3K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+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—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+4K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+4K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—