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
+6K220374EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)Medos International SARL20229—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211932Fixxsure Anterior Lumbar Plate and Screw SystemOak Tree Engineering, LLC20211—
+6K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+6K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine202110—
+6K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+6K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+6K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+6K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+6K201006K2M Navigation InstrumentsK2m, Inc.20200—
+6K201240Mariner Cap SystemSeaSpine Orthopedics Corporation20200—
+6K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+6K191217Jazz PFImplanet, S.A.20190—
+6K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+6K190751Connector SystemOrthofix, Inc.20193—
+6K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+6K182182YUKON OCT Spinal SystemK2m20185—
+6K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+6K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+6K182240PASS LP Spinal SystemMedicrea International SA20182—
+6K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+6K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+6K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+6K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+6K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc.20185—
+6K172941CASCADIA Interbody SystemK2m201852—
+6K173117NuVasive® VersaTie™ SystemNuvasive, Inc.20172—
+6K172021LigaPASSMedicrea International SA201711—
+6K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+6K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+6K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+6K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity20177—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K160362Z-Span Plate SystemZavation, LLC20163—
+6K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+6K142798PASS LP Spinal SystemMedicrea International SA201584—
+6K150049PASS LP Spinal SystemMedicrea International20150—
+6K141398Pass LP Spinal SystemMedicrea International SA2015101
+6K140738Pass LP Spinal SystemMedicrea International201447—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K132574Pass LP Spinal SystemMedicrea International20130—
+6K132575Pass LP Spinal SystemMedicrea International20130—
+6K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K113058Tiger Spine SystemCorelink, LLC201281—
+7K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+7K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+7K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+7K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+7K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+7K252729Universal Spinal SystemDouble Medical Technology, Inc.20250—
+7K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+7K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+7K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+7K240526POWEReam Xia/SerratoStryker Instruments20240—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K234051Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…Spinal Simplicity, LLC20241—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K231658VEOS Spinal Fixation SystemSpineway20230—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+7K231479TriALTIS Spine SystemMedos International SARL20238—
+7K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+7K231840CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.20230—
+7K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K230424Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral…Omnia Medical, LLC20230—
+7K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+7K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+7K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+7K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—