510(k) Report

Devices descending from K042235

684 later devices reach Orion Anterior Cervical Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC201221—
+1K112809Blue Mountain Cervical PlateQualgenix, LLC20122—
+1K042922Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc.2004677—
+2K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+2K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC201718—
+2K150036Blue Mountain Cervical Plate SystemSpineway20151—
+2K132994Anodyne Anterior Cervical Plate SystemCorelink, LLC20131—
+2K100215Archimed Remedy Cervical PlateArchimed, Inc.20100—
+2K071033T2 XVBR Spinal SystemMedtronic Sofamor Danek200750—
+2K061274Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek2006669—
+3K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+3K231145Axis Anterior Cervical Plate SystemSouthern Medical (Pty), Ltd.20230—
+3K193494Origin™ Anterior Cervical Plate SystemOrthopaedic & Spine Development20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+3K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek201747—
+3K163602Kepler I Cervical Plate SystemOrbbo Surgical, LLC20170—
+3K140234Aspiron Acp SystemU&I Corp.20146—
+3K121862Rex Anterior Cervical Plate SystemDio Medical Co., Ltd.20127—
+3K102820Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc.2010382
+3K100976T2 XVBR 1.5 Spinal SystemMedtronic Sofamor Danek USA, Inc.201049—
+3K073285Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc.2008637—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K200995Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.2020729
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+4K190053SECULOK™ ACP SystemU&I Corporation20191—
+4K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+4K182055SECULOK™ ACP SystemU&I Corporation20182—
+4K173099Fortis and Hana Anterior Cervical Plate SystemHuvexel Co., Ltd.20174—
+4K162531Sterispine CCSafe Orthopaedics20160—
+4K153373CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical…Medtronic Sofamor Danek2016110—
+4K152193Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc.20154—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+4K132366Spinal Intervertebral Body Fixation OrthosisAccel Spine20130—
+4K131520Nexus Anterior Cervical Plate SystemCore-Nexus20130—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+4K111132Genesys Spine Anterior Cervical Plate SystemGenesys Spine201141
+4K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K103137Venus Anterior Cervical PlateVerticor, Ltd.20115—
+4K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+4K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+5K242195Gemini Cervical Fusion Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+5K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+5K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation20220—
+5K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+5K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+5K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+5K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemMedynus, Inc.20220—
+5K220147Aspiron S ACP SystemU&I Corporation20220—
+5K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+5K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.20216—
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—