510(k) Report

Devices descending from K083393

292 later devices reach Xia 3 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+1K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+1K141044M.U.S.T. ExtensionMedacta International201416—
+1K132878M.U.S.T. ExtensionMedacta International201328—
+1K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+1K121568Dali Spinal Fixation SystemAccel Spine20121—
+1K121115M.U.S.T Pedicle Screw SystemMedacta International2012431
+1K120646Capsure (R) PS SystemSpine Wave, Inc.20120—
+1K111940S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC201219—
+1K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+1K100623Aesculap Implant Systems S4 Spinal SystemAesculap Implant Systems2010921
+1K092605Xia 4.5 Spinal SystemStryker Spine200998—
+2K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20260—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+2K241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.20242—
+2K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+2K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+2K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+2K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+2K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+2K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+2K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+2K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+2K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+2K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+2K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+2K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+2K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+2K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+2K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+2K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+2K162764Jazz Frame SystemImplanet, S.A.20176—
+2K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+2K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+2K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+2K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation201531—
+2K142381Xia 3 Spinal SystemStryker Corp.201483—
+2K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+2K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+2K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+2K120564Calypso SystemHogan Lovells US LLP201216—
+2K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+2K120928Synthes Matrix SystemSynthes Spine20120—
+2K120434Power Adaptor Instrument AccessoryStryker Corp.201232—
+2K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+2K111478Stryker Spine Power Adaptor (Accessory Instrument)Stryker Corporation201134—
+2K110842Atlas Spine Pedicle Screw SystemAtlas Spine, Inc.20114—
+3K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+3K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+3K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+3K243004Xpine Spinal Fixation SystemJeil Medical Corporation20240—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+3K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230482Swedge™ Pedicle Screw Fixation SystemSpinal Resources, Inc.20231—
+3K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+3K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193465CorticaLINK Spinal Fusion PlatformSpine Smith Holdings, LLC20200—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+3K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+3K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+3K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+3K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+3K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+3K180433Ennovate®Aesculap Implant Systems, LLC201811
+3K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K173484CorticaLINK Spinal Fusion PlatformLinkspine, Inc.20170—
+3K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+3K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+3K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171881JAZZ Passer BandImplanet, S.A.20170—