510(k) Report

Devices descending from K053115

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments20212—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+6K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+6K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+6K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+6K200896Solstice CCILife Spine, Inc.20200—
+6K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+6K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+6K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+6K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+6K193219G Surgical Marksman SystemG Surgical, LLC20191—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K191810Curiteva Pedicle Screw SystemCuriteva, Inc.20190—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+6K172115Navigated Instrument SystemOrthofix, Inc.20184—
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+6K171582NEO Pedicle Screw System™Neo Medical SA20170—
+6K171321K2M Navigation InstrumentsK2m201711
+6K171881JAZZ Passer BandImplanet, S.A.20170—
+6K171807ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20177—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+6K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+6K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+6K162824Z-Span Plate SystemZavation, LLC20172—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+6K161842Overwatch Spine SystemAmendia, Inc.201661
+6K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+6K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+6K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+6K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+6K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+6K143731IMPLANET Spine System (ISS)Implanet, S.A.20158—
+6K142438Nerve Monitoring Cable SystemPioneer Surgical Technology, Inc. (Rti Surgical, Inc.)20154—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+6K132303Implanet Spine SystemImplanet, S.A.201315—
+6K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+6K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+6K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+6K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+6K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K120838Synthes Matrix SystemSynthes Spine201216—
+6K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+6K120571Synthes Uss ConnectorSynthes Spine201274—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—