510(k) Report

Devices descending from K042714

838 later devices reach Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+1K132907Plif Lite and Tlif LiteSintea Plustek20140—
+1K051246Construx Mini Peek VBR SystemBlackstone Medical, Inc.2005834—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K101812Construx Mini Peek Spacer SystemOrthofix, Inc.2010291—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K060350Construx PL/TL Peek Partial VBR SystemBlackstone Medical, Inc.2006754—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K193412NEXXT MATRIXX SystemNexxt Spine, LLC20201—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K171140Matrixx SystemNexxt Spine, LLC2017145—
+3K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK…Orthofix, Inc.20166—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K132999Cervical Stand Alone SystemOrthofix, Inc.2014281—
+3K132596Proposed OptimusCustom Spine, Inc.201451
+3K133529Camber Spine Coveris Cervical CageCamber Spine201410—
+3K132894Optio-C Anterior Cervical SystemZimmer Spine, Inc.201424—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+3K122444Cervical CageEisertech, LLC201222—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+4K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+4K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+4K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+4K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+4K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+4K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K210359Hexanium TLIFSpinevision, S.A.S.20211—
+4K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+4K200953NuVasive® Cohere® Thoracolumbar Interbody SystemNu Vasive, Incorporated2020141—
+4K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+4K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+4K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+4K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+4K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+4K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+4K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+5K242303MOD-COrthomod, LLC20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—