510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K092076Aegis & Aegis II Spinal SystemCorentec Co., Ltd.20103—
+3K093294Revere Stabilization SystemGlobus Medical, Inc.2010376—
+3K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009404—
+3K092108Truss Thoracolumbar Plate SystemGlobus Medical, Inc.200942—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K090657Modification to: S4 Spinal SystemAesculap Implant Systems200994—
+3K073439Transition Stabilization SystemGlobus Medical, Inc.20092—
+3K082617Trauson General Spinal System (GSS)Trauson (Jiangsu) Medical Instrument Co., Ltd.20098—
+3K083416Revolve Stabilization SystemGlobus Medical, Inc.2009297—
+3K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine2008200—
+3K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008405—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K073517H-Link Integrated RodGlobus Medical, Inc.20080—
+3K073172Beacon Stabilization SystemGlobus Medical, Inc.2007376—
+3K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+3K062407Gateway Thoracolumbar Plate SystemGlobus Medical, Inc.2006127—
+3K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine2006710—
+3K060748Modification to Xia 4.5 Spinal SystemStryker Spine2006134—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd.20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+4K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+4K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+4K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+4K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+4K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+4K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+4K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+4K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+4K182240PASS LP Spinal SystemMedicrea International SA20182—
+4K172826Cellent Spinal SystemsJiangsu Trauhui Medical Instrument Co., Ltd.20180—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+4K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+4K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+4K173508Everest Spinal SystemK2m20189—
+4K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+4K173131Rexious Spinal Fixation SystemHuvexel Co., Ltd.20175—
+4K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K171881JAZZ Passer BandImplanet, S.A.20170—
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+4K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—