510(k) Report

Devices descending from K081917

1,008 later devices reach Depuy Spine Bengal, Concorde, Cougar, Devex and Leopard Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K181818Scarlet AL-TSpineart201864—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+4K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+4K181203Juliet TiSpineart20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+4K173702Juliet Ti LLSpineart20182—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+4K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+4K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+4K170395Talos® Lumbar (HA) PEEK IBF DevicesMeditech Spine, LLC201710—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K162206Zavation IBFZavation, LLC201724—
+4K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP2016161—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.20161—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device…Spineology, Inc.201627—
+4K152622Alta ACDF SystemBiomet Spine20160—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K141005Z-Link CervicalZavation, LLC20144—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—