510(k) Report

Devices descending from K010108

666 later devices reach Uss-Line Extension through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+5K232572Kalitec Navigated Instrument SystemKalitec Direct, LLC Doing Business AS Kalitec Medical20230—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K233332Statera-C™ Spinal SystemK&J Consulting Corp.20230—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+5K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K230974NIDO™ Pedicle Screw SystemKalitec Medical20230—
+5K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+5K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+5K223558CUVIS-spineCurexo, Inc.20230—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato®…Stryker Spine20234—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+5K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223350Remi Robotic Navigation SystemFusion Robotics, LLC20230—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223273ASTRA Spine SystemSpinecraft, LLC20228—
+5K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+5K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K201569CUVIS-spineCurexo, Inc.20212—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K202184Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC20215—
+5K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+5K200245EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine SystemMedos International Sàrl202012—
+5K200666Stryker Xia 3 Power AdaptorStryker Spine20203—
+5K200281The Gecko Spinal SystemOrtho Development Corporation20200—
+5K200097Response BandLoc Spinal FixationOrthoPediatrics Corp.20200—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+5K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+5K182000AQrate Robotic Assistance SystemGlobus Medical, Inc.20191—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+5K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+5K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+5K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K172194Connector SystemOrthofix, Inc.2017162
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171456Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine20170—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151