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
+5K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.201678—
+5K160698LigaPASSMedicrea International SA201612—
+5K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+5K161499VertiForm Posterior Fixation SystemNext Orthosurgical20161—
+5K160465Spinal Elements' Spinous Process Plate SystemSpinal Elements, Inc.20160—
+5K161265NuVasive® VersaTie SystemNu Vasive, Incorporated20163—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+5K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc.20160—
+5K153413PASS LP Spinal SystemMedicrea International SA20160—
+5K153370Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m, Incorporated201617—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+5K151740JAZZ SystemImplanet, S.A.201512—
+5K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC20158—
+5K151216Everest Spinal SystemK2m, Inc.201511—
+5K150380ProMIS Fixation SystemPremia Spine, Ltd.20154—
+5K143759JAZZ SystemImplanet, S.A.201513—
+5K142217Reliance Interspinous Plate SystemReliance Medical Systems, LLC20150—
+5K150449LITe Plate SystemStryker Corp.201524—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K142378Interspinous Plate SystemPrecision Spine, Inc.20143—
+5K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148—
+5K140260Skyhawk Lateral Plate SystemOrthofix, Inc.201414—
+5K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+5K133617Jazz SystemImplanet, S.A.201414—
+5K131833Centurion Poct SystemOrthofix, Inc.20142—
+5K132968Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine201312—
+5K131533Cayman MI Plate SystemK2m, Inc.201372—
+5K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A.20134—
+5K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K123138Pass LP Spinal SystemMedicrea International2013132—
+5K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K110906Apex Spine SystemSpinecraft, LLC2011103—
+5K090320Conquest Spinal SystemLife Spine20092—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+6K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+6K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+6K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+6K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+6K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+6K252322SIros-X SystemGenesys Spine20250—
+6K253249TriALTIS™ Spine SystemMedos International SARL20251—
+6K253331PressON Spinal Fixation SystemNexus Spine20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+6K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC20251—
+6K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.20250—
+6K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd.20250—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+6K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+6K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+6K241258Ingenix Spinal SystemIngenium Spine20240—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+6K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+6K233300POWEReam 1/4 DriveStryker Instruments20231—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20232—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+6K231844ProMIS™ Fixation SystemPremia Spine, Ltd.20231—
+6K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+6K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+6K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K220843OAKTREE Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20220—
+6K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+6K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+6K222473EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra RodsMedos-International Sarl20221—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+6K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC20224—