510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+4K170942The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP20170—
+4K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+4K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K150684WASTON General Spinal SystemChangzhou Waston Medical Appliance Co., Ltd.20150—
+4K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+4K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+4K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K142699LITe Plate SystemStryker Corporation201446—
+4K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K134011General Spinal SystemChangzhou Dean Medical Instrument Co, Ltd.20140—
+4K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+4K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+4K140229General Spinal SystemTianjin Walkman Biomaterial Co., Ltd.20140—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+4K132303Implanet Spine SystemImplanet, S.A.201315—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+4K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+4K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+4K123717UcentumUlrich GmbH & Co. KG2013171
+4K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+4K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+4K120838Synthes Matrix SystemSynthes Spine201216—
+4K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20125—
+4K120092Plymouth Thoracolumbar Plate SystemGlobus Medical, Inc.201241—
+4K111690Devine Spinal SystemChangzhou Orthmed Medical Instrument Co., Ltd.20113—
+4K103671Genesys Spine Tilock SystemGenesys Spine20118—
+4K110963Ellipse Occipito-Cervico-Thoracic Spinal SystemGlobus Medical, Inc.201198—
+4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+4K100061Cayman Screws Model K2-12-1000-XX, K2-12-1001-XXK2m, Inc.201073—
+4K092610Modification to Beacon Stabilization SystemGlobus Medical, Inc.2009375—
+4K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+4K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+4K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+4K080767Conquest Spinal SystemLife Spine200821—
+4K072605Malibu Spinal SystemSeaspine, Inc.200767—
+4K072426Atlas Spine Pedicle Screw SystemAtlas Spine, LLC200751
+4K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+5K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+5K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+5K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+5K252322SIros-X SystemGenesys Spine20250—
+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—
+5K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+5K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+5K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+5K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+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—
+5K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+5K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+5K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+5K240392JAZZ Spinal SystemImplanet20241—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+5K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+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—
+5K231515MySpine Cervical GuidesMedacta International S.A.20230—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—