510(k) Report

Devices descending from K071373

430 later devices reach Stryker Spine Xia Iii Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K203482M.U.S.T. Pedicle Screw Extension and Long Tab ImplantsMedacta International S.A.20215—
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+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—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K193365M.U.S.T. Pedicle Screw SystemMedacta International S.A.20207—
+3K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+3K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+3K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+3K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+3K182240PASS LP Spinal SystemMedicrea International SA20182—
+3K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+3K180655Viking Lumbar Polyaxial Screw SystemPresidio Surgical20180—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+3K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+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—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.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—
+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—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K162764Jazz Frame SystemImplanet, S.A.20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K160722CorticaLINK Spinal Fusion PlatformFacetlink Dba Linkspine20162—
+3K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+3K153664M.U.S.T. Pedicle Screw SystemMedacta International201624—
+3K151216Everest Spinal SystemK2m, Inc.201511—
+3K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K123939S4 Spinal SystemAesculap Implant Systems, Inc.20133—
+3K121670Medyssey Cannulated Pedicle ScrewMedyssey Co, Ltd.201311—
+3K120564Calypso SystemHogan Lovells US LLP201216—
+3K111634Xenon (TM) Pedicle Screw SystemAlphatec Spine, Inc.20120—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc.20112—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K254148VERTICALE GPS InstrumentsSilony Medical GmbH20260—
+4K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20260—
+4K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.20260—
+4K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+4K252322SIros-X SystemGenesys Spine20250—
+4K253249TriALTIS™ Spine SystemMedos International SARL20251—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K241525ExcelsiusXR™Globus Medical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+4K243326Dynamis Robotic Surgical SystemLEM Surgical AG20251—
+4K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K240160EGPS Navigated InstrumentsAstura Medical20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K233300POWEReam 1/4 DriveStryker Instruments20231—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+4K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+4K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+4K223558CUVIS-spineCurexo, Inc.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+4K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+4K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+4K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—