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
+3K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232561Ripley Spinal Screw System by SAGICOSagico VA USA, LLC20230—
+3K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+3K232218Zenius™ Spinal SystemMedyssey USA, Inc.20230—
+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—
+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—
+3K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+3K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+3K220285PINE Pedicle Screw SystemTdm Co., Ltd.20220—
+3K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+3K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+3K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+3K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc.20211—
+3K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+3K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+3K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+3K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+3K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+3K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+3K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K180220SAGICO OSI Spinal System by OsimplantSpinal Analytics & Geometrical Implant Co, LLC20181—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K173508Everest Spinal SystemK2m20189—
+3K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+3K171526Zenius™, lliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20172—
+3K171651Excelsius GPSGlobus Medical, Inc.2017691
+3K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+3K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC20163—
+3K162061M.U.S.T. Pedicle Screw SystemMedacta International S.A.201615—
+3K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K161028K2M Growing Spine SystemK2m, Inc.20163—
+3K160989NuVasive® Reline® SystemNu Vasive, Incorporated201667—
+3K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsChoicespine, LP201673—
+3K151974Polaris Spinal SystemBiomet Spine201516—
+3K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC20154—
+3K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158—
+3K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+3K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+3K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+3K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+3K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+3K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+3K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+3K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+3K141147Range Spinal SystemK2m, Inc.20141—
+3K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+3K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+3K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek201485—
+3K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+3K132403Annextm Adjacent Level SystemSpine Wave, Inc.20142—
+3K132878M.U.S.T. ExtensionMedacta International201328—
+3K132757Everest Spinal SystemK2m, Inc.201341—
+3K132303Implanet Spine SystemImplanet, S.A.201315—
+3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013132—
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K131784Range Spinal SystemK2m, Inc.201334—
+3K131878Lliad, Kora, Zenius Pedicle Screw SystemMedyssey USA, Inc.20138—
+3K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+3K130438Axle Interspinous Fusion SystemX-Spine Systems, Inc.2013181
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K122877Range Spinal System, Small StatureK2m, Inc.201334—
+3K130330Range Spinal SystemK2m, Inc.201336—
+3K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371