510(k) Report

Devices descending from K050461

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+5K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+5K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+5K143110GALAXY MIS Screw SystemBm Korea20152—
+5K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+5K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+5K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+5K141044M.U.S.T. ExtensionMedacta International201416—
+5K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+5K132878M.U.S.T. ExtensionMedacta International201328—
+5K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+5K130877Expedium Spine SystemMedos International SARL20138—
+5K122877Range Spinal System, Small StatureK2m, Inc.201334—
+5K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+5K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+5K122845ES2 Spinal System Model 48280XXXXStryker Spine201228—
+5K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+5K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+5K120099Range Spinal System (Mesa and Denali)K2m, Inc.201253—
+5K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+5K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+5K110551Expedium Spine SystemJohnson & Johnson20111—
+5K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+5K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+5K101070Expedium Spine SystemMedos International SARL20102601
+5K102235Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine2010109—
+5K101144Modification to:Radius Spinal SystemStryker Spine201090—
+5K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+5K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+5K0910675.5 Polaris Spinal SystemBiomet Spine200979—
+5K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+5K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+5K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+5K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+6K243249TriALTIS™ Spine SystemMedos International SARL20250—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233684TriALTIS™ Spine SystemMedos International SARL20234—
+6K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+6K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+6K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+6K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+6K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+6K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+6K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+6K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+6K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+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—
+6K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+6K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+6K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+6K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+6K171651Excelsius GPSGlobus Medical, Inc.2017691
+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—
+6K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+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—
+6K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+6K162764Jazz Frame SystemImplanet, S.A.20176—
+6K162367Erisma® LP MISClariance, Sas20162—
+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—