510(k) Report

Devices descending from K043206

1,571 later devices reach Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+4K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K191796Neo Cage SystemNeo Medical SA20190—
+4K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+4K1803473d CageFims Co., Ltd.20190—
+4K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+4K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+4K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+4K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+4K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+4K190488ProLift Expandable SystemLife Spine, Inc.201916—
+4K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+4K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+4K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+4K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+4K190380nvcNvision Biomedical Technologies, Inc.20193—
+4K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+4K181048Neo Cage System TMNeo Medical SA20191—
+4K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+4K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+4K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+4K181397DualXInnovasive, Inc.201815—
+4K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+4K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K181337Sypher Spacer SystemBiogennix, LLC20180—
+4K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+4K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+4K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+4K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+4K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+4K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+4K172480icotec Interbody Cage SystemIcotec AG20185—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+4K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+4K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+4K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+4K171312FortiCore®Nanovis, LLC20183—
+4K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+4K173508Everest Spinal SystemK2m20189—
+4K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+4K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+4K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+4K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+4K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+4K172419Velofix™ TLIF CageU&I Corporation20172—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K172424Velofix™ SA Cervical CageU&I Corporation201751
+4K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+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—
+4K163366Shanghai Sanyou CARMEN Cervical Fusion SystemShanghai Sanyou Medical Co, Ltd.20170—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+4K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+4K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+4K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+4K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+4K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+4K162496Foundation 3D InterbodyCorelink, LLC201782—
+4K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+4K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+4K163474CAVUX CervicalCage-L SA SystemProvidence Medical Technology, Inc.20170—
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K160924Amendia Interbody Fusion DevicesAmendia, Inc.2016166—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K160958Battalion Universal Spacer SystemAlphatec Spine2016114—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K160916CoRoent® Ti-C SystemNu Vasive, Incorporated2016139—
+4K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K151939COALITION SpacersGlobus Medical, Inc.2016152—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632