510(k) Report

Devices descending from K031175

928 later devices reach Click'x Monoaxial Screws and Hooks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+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—
+5K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+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—
+5K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd.20232—
+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—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+5K223494CD Horizon Spinal SystemMedtronic202317—
+5K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+5K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+5K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+5K222698CUVIS-spineCurexo, Inc.20220—
+5K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…Spinal Simplicity, LLC20223—
+5K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+5K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+5K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+5K220570M.U.S.T. MINI Posterior Cervical Screws System ExtensionMedacta International S.A.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC20215—
+5K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+5K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+5K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+5K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+5K211323ASTRA Spine SystemSpinecraft, LLC202112—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+5K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC20206—
+5K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+5K203149M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20200—
+5K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+5K202528Cannulated Power Driver AttachmentK2m, Inc.20200—
+5K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+5K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+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—
+5K200130M.U.S.T. MINI Posterior Cervical Screws SystemMedacta International S.A.20206—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K190016Lateral Plate SystemCorelink, LLC201915—
+5K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+5K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+5K190567KeYi Spinal Fixation SystemBeijing Keyi Medical Device Technology Co., Ltd.20190—
+5K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+5K182837M.U.S.T. Mini ExtensionMedacta International S.A.20191—
+5K182721Choice Spine Navigation SystemChoicespine, LP20192—
+5K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K182508Saxxony™ Posterior Cervical Thoracic SystemNexxt Spine, LLC20184—
+5K181799ResCUBE™ Ligament Fixation SystemCousin Biotech Sas20180—
+5K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20183—
+5K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+5K172115Navigated Instrument SystemOrthofix, Inc.20184—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173126Arisstos™ Spinal SystemIngenium Spine20171—
+5K172469TiLock Modular Spinal SystemGenesys Spine20170—
+5K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+5K172808CosmoLock Pedicle Screw SystemKalitec Direct, LLC20172—
+5K172724XIA® 4.5 Spinal System, Power Adaptor Instrument AccessoryStryker Corporation20179—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K171321K2M Navigation InstrumentsK2m201711
+5K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+5K172194Connector SystemOrthofix, Inc.2017162
+5K171881JAZZ Passer BandImplanet, S.A.20170—
+5K171838TiLock2 Spinal SystemGenesys Spine20174—
+5K171509Iliad® Pedicle Screw System and Zenius® Pedicle Screw SystemMedyssey USA, Inc.20171—
+5K170730JAZZ System, including JAZZ BandImplanet, S.A.20175—
+5K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation2017151
+5K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+5K161332NILE Proximal Fixation Spinal SystemK2m, Inc.20175—
+5K163471Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC20176—
+5K162786PASS LP Spinal SystemMedicrea International SA20176—
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K161016Z-Clamp ISP SystemZavation, LLC20160—
+5K161842Overwatch Spine SystemAmendia, Inc.201661
+5K162143FixxSure® X-LinkInnovasis, Inc.20160—