510(k) Report

Devices descending from K013823

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+3K223273ASTRA Spine SystemSpinecraft, LLC20228—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211323ASTRA Spine SystemSpinecraft, LLC202112—
+3K210549ARx Spinal SystemLife Spine, Inc.20211—
+3K210427M.U.S.T. Midline Cortical (MC) Screw SystemMedacta International S.A.20210—
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+3K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+3K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+3K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemStryker Corporation20208—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+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—
+3K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+3K171369M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20178—
+3K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+3K163011PHA S1 Spinal SystemPhamedica, Inc.20170—
+3K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+3K170108Xultan 5.5 Pedicle Screw SystemMet One Technologies20172—
+3K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K162367Erisma® LP MISClariance, Sas20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K160320PremierShandong Weigao Orthopaedic Device Co., Ltd.20161—
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150647Polyscrew Pedicle Screw SystemNew Era Orthopedics, LLC201501
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K140400ES2 Neuromonitoring Accessory InstrumentsStryker Corporation20149—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K123783Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol ImplantsGlobus Medical, Inc.201397—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+3K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC20135—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K111953Nautilus Spinal SystemLife Spine20123—
+3K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K121342Xia 4.5 Spinal SystemStryker Corp.201288—
+3K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc.2012260—
+3K120928Synthes Matrix SystemSynthes Spine20120—
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+3K111729Pilot Spinal SystemLife Spine, Inc.201113—
+3K111449Revolve Additional ImplantsGlobus Medical, Inc.2011236—
+3K111479Revere CrosstopGlobus Medical, Inc.2011232—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+3K103072Revere Sacral PlatesGlobus Medical, Inc.2011233—
+3K101144Modification to:Radius Spinal SystemStryker Spine201090—
+3K100788Cocr RodsGlobus Medical, Inc.2010374—