510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K150294DPZ Pedicular Fixation SystemOsteomed Implantes, Ltda20150—
+3K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K141253New Era Orthopaedics Polyscrew Pedicle Screw SystemNew Era Orthopaedics, LLC201511
+3K142699LITe Plate SystemStryker Corporation201446—
+3K142381Xia 3 Spinal SystemStryker Corp.201483—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+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—
+3K132361Everest Spinal SystemK2m, Inc.201334—
+3K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+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
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K113666Xia 3 Spinal SystemStryker Spine2012251—
+3K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+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—
+3K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+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—
+3K100737Modification to: Trio+Spinal Fixation SystemStryker Spine201086—
+3K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+3K092631Mantis Redux Spinal SystemStryker Spine2009110—
+3K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+3K083393Xia 3 Spinal SystemStryker Spine20092921
+3K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K080767Conquest Spinal SystemLife Spine200821—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+3K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+3K063428Xia Stainless Steel Spinal SystemStryker Spine2006204—
+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—
+4K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, 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—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+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—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—