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
+1K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+1K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+1K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+1K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+1K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+1K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+1K081383Reliance VBS SystemReliance Medical Systems, LLC20080—
+1K063637Reliance VBS SystemReliance Medical Systems, LLC20071—
+1K063464Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20072—
+1K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.20071,406—
+1K061151Pioneer Vertebral Spacer (Vertebral Spacer)Pioneer Surgical Technology2006801—
+1K043479MC+ Partial VBRLdr Spine USA20051,214—
+2K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+2K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+2K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+2K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+2K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+2K163673Fortilink™-C with TETRAfuse™ 3D TechnologyRti Surgical, Inc.201711—
+2K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company20160—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K131724Pioneer Maxfuse Vertebral Body Replacement DevicePioneer Surgical Technology, Inc.201373—
+2K132718Integrity Spine Core SystemIntegrity Spine20131—
+2K123206Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical2013454—
+2K123388K7C SpacerK7, LLC20130—
+2K121116Plateau Spacer SystemLife Spine201213—
+2K120656Everest Spinal SystemK2m, Inc.201243—
+2K110659Medical Concepts Interbody Fusion SystemMedical Concepts, Inc.20111—
+2K103034Genesys Spine Interbody Fusion SystemGenesys Spine20101371
+2K100042Difusion Technologies Xiphos Interbody Fusion SystemDifusion Technologies2010864—
+2K092904Pathway Ivb/VBRCustom Spine, Inc.2009296—
+2K091088LDR Spine Cervical Interbody Fusion SystemLdr Spine USA2009901—
+2K090064Eminent Spine Interbody Fusion SystemEminent Spine20097011
+2K083857LDR Spine Roi-C ImplantLdr Spine USA2009902—
+2K081880Atlas Spine SpacerAtlas Spine, Inc.20080—
+2K080971Spinesmith Cimplicity Spinal SystemSpine Smith Partners L.P.2008406—
+2K080728LDR Spine Roi-C ImplantLdr Spine USA2008903—
+2K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+2K080572LDR Spine Roi-a ImplantLdr Spine USA2008113—
+2K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+2K071497Atlas Spine Vertebral Body ReplacementAtlas Spine, Inc.20070—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+3K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K230219Eminent Spine 3D Lumbar Interbody Fusion SystemsEminent Spine, LLC20234—
+3K230026SqualeImplanet, S.A.20230—
+3K223043The Integrity Spine Core SystemIntegrity Spine20230—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K212701Eminent Spine 3D Cervical Interbody Fusion SystemEminent Spine20235—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+3K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+3K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+3K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+3K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K190498Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs…Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20197—
+3K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+3K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+3K182477Cervical SpacerAdditive Implants, LLC201915—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+3K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+3K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+3K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+3K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+3K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+3K172009Cascadia Interbody SystemK2m, Inc.2017433
+3K173148ACIFColigne AG20171—
+3K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+3K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+3K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+3K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+3K170844Gemini-C Hybrid Cervical Interbody SystemOsseus Fusion Systems, LLC20170—
+3K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+3K163494Summit Spine Channel Cervical Interbody Fusion SystemSummit Spine20171—
+3K162206Zavation IBFZavation, LLC201724—
+3K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+3K160663Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF)Evolution Spine, LLC20160—
+3K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion SystemGenesys Spine201619—