510(k) Report

Devices descending from K060361

734 later devices reach Xia Spinal System, Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+4K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+4K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+4K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+4K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+4K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+4K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+4K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+4K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+4K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+4K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+4K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+4K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K173508Everest Spinal SystemK2m20189—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K171651Excelsius GPSGlobus Medical, Inc.2017691
+4K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+4K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+4K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+4K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+4K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+4K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+4K162764Jazz Frame SystemImplanet, S.A.20176—
+4K162367Erisma® LP MISClariance, Sas20162—
+4K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+4K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+4K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+4K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+4K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+4K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K143350Nile Alternative FixationK2m, Inc.201510—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+4K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+4K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+4K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+4K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+4K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+4K133103Aversion Pedicle Screw SystemK7, LLC20140—
+4K133369Tiger Spine SystemCorelink, LLC201429—
+4K131250Tiger Spine SystemCorelink, LLC201340—
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+4K131343Reform Pedicle Screw SystemSpinal USA201331—
+4K130279Reform Pedicle Screw SystemSpinal USA201331—
+4K131030Range Spinal SystemK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+4K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+4K122145Lanx Spinal Fixation SystemLanx, Inc.201271
+4K120564Calypso SystemHogan Lovells US LLP201216—
+4K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine20121—
+4K121020Viper SystemDepuy Spine, Inc.201294—
+4K113044Synthes MirsSynthes Spine2011933
+4K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+4K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC)201176—
+4K110906Apex Spine SystemSpinecraft, LLC2011103—