510(k) Report

Devices descending from K002858

749 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+8K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+8K172115Navigated Instrument SystemOrthofix, Inc.20184—
+8K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+8K171582NEO Pedicle Screw System™Neo Medical SA20170—
+8K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+8K171838TiLock2 Spinal SystemGenesys Spine20174—
+8K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+8K170647Connector SystemOrthofix, Inc.201718—
+8K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+8K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+8K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+8K161842Overwatch Spine SystemAmendia, Inc.201661
+8K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+8K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+8K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+8K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+8K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+8K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+8K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+8K151727Everest Spinal SystemK2m, Inc.201511—
+8K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+8K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+8K141147Range Spinal SystemK2m, Inc.20141—
+8K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+8K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+8K132361Everest Spinal SystemK2m, Inc.201334—
+8K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+8K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+8K124058Creo Stabilization SystemGlobus Medical, Inc.2013172—
+8K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+8K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+8K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+8K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+8K120571Synthes Uss ConnectorSynthes Spine201274—
+8K113058Tiger Spine SystemCorelink, LLC201281—
+9K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260369Dynamis Robotic Surgical SystemLEM Surgical AG20260—
+9K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+9K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+9K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+9K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+9K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+9K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K231515MySpine Cervical GuidesMedacta International S.A.20230—
+9K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+9K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+9K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+9K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+9K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+9K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+9K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+9K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+9K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+9K222698CUVIS-spineCurexo, Inc.20220—
+9K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+9K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+9K221244CD Horizon™ Spinal SystemMedtronic202220—
+9K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+9K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+9K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+9K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+9K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+9K203452Nano FortiFix® SystemNanovis, LLC20200—
+9K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+9K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+9K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+9K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+9K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+9K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+9K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+9K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+9K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+9K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+9K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+9K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+9K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+9K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+9K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+9K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—