510(k) Report

Devices descending from K012870

908 later devices reach Xia Stainless Steel System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+6K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+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—
+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
+6K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+6K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+6K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+6K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K143350Nile Alternative FixationK2m, Inc.201510—
+6K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+6K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+6K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+6K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+6K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+6K133402K2M Modular HooksK2m, Inc.20140—
+6K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+6K133103Aversion Pedicle Screw SystemK7, LLC20140—
+6K133369Tiger Spine SystemCorelink, LLC201429—
+6K131250Tiger Spine SystemCorelink, LLC201340—
+6K131784Range Spinal SystemK2m, Inc.201334—
+6K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+6K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+6K131030Range Spinal SystemK2m, Inc.201334—
+6K130330Range Spinal SystemK2m, Inc.201336—
+6K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+6K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+6K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+6K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+6K120564Calypso SystemHogan Lovells US LLP201216—
+6K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+6K121020Viper SystemDepuy Spine, Inc.201294—
+6K113044Synthes MirsSynthes Spine2011933
+6K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+6K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+6K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+6K101993Viper System, Expedium SystemDepuy Spine, Inc.20101628
+6K100845Pathfinder II, Minimally Invasie Pedicle Screw System Model 3500 SeriesZimmer Spine, Inc.201045
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+7K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+7K243249TriALTIS™ Spine SystemMedos International SARL20250—