510(k) Report

Devices descending from K061151

801 later devices reach Pioneer Vertebral Spacer (Vertebral Spacer) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+5K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+5K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+5K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+5K200052CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemOrthofix, Inc.202013—
+5K200312Tryptik TiSpineart20202—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K192906Mecta-C Stand AloneMedacta International S.A.20201—
+5K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated20201—
+5K193255Largo PEEK Interbody SystemFlospine, LLC20201—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K193258ProLift Expandable SystemLife Spine, Inc.20203—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K190721LongBow TiLife Spine, Inc.20190—
+5K1803473d CageFims Co., Ltd.20190—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc.20192—
+5K190147COLOSSEUM MeshGlobus Medical, Inc.20190—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K183239CoreLink F3D™ Lateral SystemCorelink, LLC20188—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K173982FORTIFY Corpectomy SpacersGlobus Medical, Inc.20188—
+5K181386NuVasive Brigade Lateral SystemNu Vasive, Incorporated2018158—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K180556Corelink Foundation 3D Anterior Lumbar SystemCorelink, LLC20185—
+5K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc.2018111—
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+5K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+5K172816TiGer Shark™ SystemChoicespine, LP201859—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K173508Everest Spinal SystemK2m20189—
+5K171434ROCCIA® MultiLIFSilony Medical GmbH20174—
+5K172926SeaSpine Vu cPOD, Zuma-C, Complete CervicalSeaSpine Orthopedics Corporation201761—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K170235Lucent®Spinal Elements, Inc.2017107—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+5K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+5K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—
+5K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+5K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+5K151727Everest Spinal SystemK2m, Inc.201511—
+5K142360Everest Spinal SystemK2m, Inc.201522—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+5K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+5K141147Range Spinal SystemK2m, Inc.20141—
+6K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+6K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+6K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+6K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+6K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+6K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+6K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253260ORIO-3D Cage SystemSpineCraft20260—
+6K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—