510(k) Report

Devices descending from K042714

838 later devices reach Fidji-Vertebral Body Replacement Type 1, 2, 3 and 4 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K212450Keos Anterior Cervical Interbody Fusion Device SystemKeos20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+6K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+6K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+6K212358Romero Cervical CageSpineup, Inc.20226—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+6K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+6K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+6K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+6K202032Idys LLIF 3DTiClariance, Sas20210—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+6K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+6K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+6K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+6K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K192993Scarlet AL-TSpineart20201—
+6K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K191134IB3D AlifMedicrea International SA20191—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+6K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+6K190680Favo S-TlifSilony Medical GmbH20190—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+6K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+6K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+6K182920MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar…MiRus, LLC20199—
+6K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+6K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+6K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+6K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+6K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+6K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+6K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+6K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+6K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+6K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+6K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+6K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+6K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+6K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+6K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+6K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+6K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+6K170962NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated2017304—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K163707NuVasive CoRoent Ti-C SystemNu Vasive, Incorporated201719—
+6K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+6K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2017276—
+6K163409Rampart (TM) T Lumbar Interbody Fusion DeviceSpineology, Inc.20170—
+6K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+6K161993Leva® Anterior Interbody SystemSpine Wave, Inc.20160—
+6K162138NuVasive CoRoent Small Ti-C SystemNu Vasive, Incorporated2016135—