510(k) Report

Devices descending from K031090

891 later devices reach Modification to Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+6K240392JAZZ Spinal SystemImplanet20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K240526POWEReam Xia/SerratoStryker Instruments20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+6K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+6K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+6K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+6K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+6K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+6K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+6K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+6K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+6K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc.20226—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+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—
+6K193129Yukon OCT Spinal SystemK2m, Inc.202001
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+6K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+6K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+6K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+6K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+6K183381Navigation Enabled InstrumentsStryker20191—
+6K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+6K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+6K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+6K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171321K2M Navigation InstrumentsK2m201711
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+6K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+6K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+6K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+6K162824Z-Span Plate SystemZavation, LLC20172—
+6K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+6K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+6K161028K2M Growing Spine SystemK2m, Inc.20163—
+6K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+6K151977icotec Pedicle SystemIcotec AG201630—
+6K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+6K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—