510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+7K241846E3D™-C Interbody SystemEvolution Spine20246—
+7K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+7K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+7K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+7K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+7K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+7K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+7K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K192680Percusys® Plus Pedicle Screw SystemJoimax GmbH20190—
+7K193219G Surgical Marksman SystemG Surgical, LLC20191—
+7K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K183381Navigation Enabled InstrumentsStryker20191—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K181188EVEREST Spinal SystemK2m, Inc.20186—
+7K171582NEO Pedicle Screw System™Neo Medical SA20170—
+7K171321K2M Navigation InstrumentsK2m201711
+7K163181TRANSLACE™ Spinal Tethering SystemMedtronic Sofamor Danek USA, Inc.20172—
+7K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+7K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+7K162824Z-Span Plate SystemZavation, LLC20172—
+7K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K151977icotec Pedicle SystemIcotec AG201630—
+7K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+7K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+7K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+7K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+7K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.201511
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K132884Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20130—
+7K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company2013139—
+7K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC)20120—
+7K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+7K121671Pathfinder NXT Minimally Invasive Pedicle Screw SystemZimmer Spine, Inc.20120—
+7K120571Synthes Uss ConnectorSynthes Spine201274—
+8K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K260038E3D™-C Interbody SystemEvolution Spine20261—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+8K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K243419Altus Spine Navigation SystemAltus Partners, LLC20250—