510(k) Report

Devices descending from K040928

1,504 later devices reach Expandable Peek VBR Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+6K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+6K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+6K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K211413BEE PLIF CageNGMedical GmbH20211—
+6K210800IO Expandable Lumbar Interbody Fusion SystemMiRus, LLC20212—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+6K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+6K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+6K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+6K201671A-Link ZAcuity Surgical Devices, LLC202125—
+6K200919Idys ALIF 3DTiClariance20210—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K210359Hexanium TLIFSpinevision, S.A.S.20211—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+6K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+6K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+6K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+6K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+6K200316UNiD IB3D ALIFMedicrea International SA20200—
+6K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+6K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+6K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+6K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+6K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+6K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+6K193593NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated2020157—
+6K192897icotec Cervical CageIcotec AG20201—
+6K193521Steerable Plateau TiLife Spine, Inc.20201—
+6K193370Nexxt Matrixx SystemNexxt Spine, LLC20202—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+6K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+6K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+6K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+6K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+6K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+6K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+6K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+6K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+6K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+6K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+6K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+6K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+6K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+6K191263Idys ALIF TiVacClariance, Sas20190—
+6K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+6K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+6K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+6K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+6K183083Shoreline Cervical Interbody RT SystemSeaSpine Orthopedics Corporation201960—
+6K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+6K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+6K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+6K182470Plateau Spacer SystemLife Spine20180—
+6K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+6K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+6K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+6K181818Scarlet AL-TSpineart201864—
+6K181337Sypher Spacer SystemBiogennix, LLC20180—
+6K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+6K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+6K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+6K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+6K181203Juliet TiSpineart20181—
+6K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+6K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+6K172480icotec Interbody Cage SystemIcotec AG20185—
+6K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+6K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+6K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+6K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+6K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+6K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+6K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+6K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+6K172009Cascadia Interbody SystemK2m, Inc.2017433
+6K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+6K172756Varian cageMedyssey USA, Inc.20171—
+6K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+6K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+6K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+6K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+6K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+6K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—