510(k) Report

Devices descending from K033926

763 later devices reach Hourglass Vertebral Body Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K220261NEST-C Interbody SystemPaonan Biotech Co., Ltd.20230—
+4K230583Tryptik TiSpineart SA20231—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+4K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+4K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+4K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K200919Idys ALIF 3DTiClariance20210—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K202032Idys LLIF 3DTiClariance, Sas20210—
+4K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+4K201585Monterey AL Interbody SystemStryker Corporation202044
+4K200920Idys ALIF ZP 3DTiClariance, Sas20203—
+4K200991EVOL Spinal Interbody SystemCutting Edge Spine, LLC20200—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192993Scarlet AL-TSpineart20201—
+4K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+4K193174Keos Lumbar IBFDKeos20190—
+4K192168Idys ALIF ZP 3DTiClariance, Sas20195—
+4K191134IB3D AlifMedicrea International SA20191—
+4K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+4K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+4K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+4K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K191263Idys ALIF TiVacClariance, Sas20190—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+4K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+4K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K180695FBC 921 (Alif)Fbc Device Aps20180—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+4K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K171630LumFuse-TPPrecifit Medical, Ltd.20171—
+4K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161379ELSA SpacersGlobus Medical, Inc.2016155—
+4K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K152304Tritanium PL CageStryker20154481
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K141135Juliet LLSpineart2014146—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—