510(k) Report

Devices descending from K052761

735 later devices reach Modification to: Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+5K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+5K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+5K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+5K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+5K240526POWEReam Xia/SerratoStryker Instruments20240—
+5K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+5K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+5K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+5K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+5K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+5K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+5K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+5K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+5K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+5K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+5K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+5K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+5K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+5K192268Europa Pedicle Screw SystemMiRus, LLC20190—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+5K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+5K191757EUROPA Pedicle Screw SystemMiRus, LLC20191—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K190376PASS LP Spinal SystemMedicrea International SA201915
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+5K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K180433Ennovate®Aesculap Implant Systems, LLC201811
+5K173508Everest Spinal SystemK2m20189—
+5K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+5K171651Excelsius GPSGlobus Medical, Inc.2017691
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+5K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+5K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+5K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+5K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+5K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+5K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+5K162764Jazz Frame SystemImplanet, S.A.20176—
+5K162367Erisma® LP MISClariance, Sas20162—
+5K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+5K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+5K161028K2M Growing Spine SystemK2m, Inc.20163—
+5K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+5K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+5K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+5K143350Nile Alternative FixationK2m, Inc.201510—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K143200MIS Z-Pedicle Screw SystemZ-Medical GmbH & Co. KG201514—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+5K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+5K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+5K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+5K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+5K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+5K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+5K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+5K133103Aversion Pedicle Screw SystemK7, LLC20140—
+5K133369Tiger Spine SystemCorelink, LLC201429—
+5K131250Tiger Spine SystemCorelink, LLC201340—
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+5K131784Range Spinal SystemK2m, Inc.201334—
+5K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+5K131343Reform Pedicle Screw SystemSpinal USA201331—
+5K130279Reform Pedicle Screw SystemSpinal USA201331—
+5K131030Range Spinal SystemK2m, Inc.201334—
+5K130330Range Spinal SystemK2m, Inc.201336—
+5K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+5K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—