510(k) Report

Devices descending from K100042

864 later devices reach Difusion Technologies Xiphos Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K1803473d CageFims Co., Ltd.20190—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+4K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+4K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+4K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K182477Cervical SpacerAdditive Implants, LLC201915—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+4K182470Plateau Spacer SystemLife Spine20180—
+4K181818Scarlet AL-TSpineart201864—
+4K181397DualXInnovasive, Inc.201815—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+4K181203Juliet TiSpineart20181—
+4K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+4K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+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—
+4K172816TiGer Shark™ SystemChoicespine, LP201859—
+4K171312FortiCore®Nanovis, LLC20183—
+4K173702Juliet Ti LLSpineart20182—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+4K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172083Idys™ ALIF SystemClariance, Sas20177—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+4K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+4K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+4K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+4K171704CAPRI Corpectomy Cage SystemK2m201710—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171140Matrixx SystemNexxt Spine, LLC2017145—
+4K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+4K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+4K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+4K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+4K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+4K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc.201631—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160631Keos Lumbar IBFDKeos20161—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—