510(k) Report

Devices descending from K022791

581 later devices reach Synthes Anterior Tension Band (Atb) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200846Balteum™ Lumbar Plate SystemHuvexel Co., Ltd.20204—
+1K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+1K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS…Signature Orthopaedics Pty, Ltd.20172—
+1K171538Cure™ Lumbar Plate SystemMeditech Spine, LLC201719—
+1K124034Mectalif AnteriorMedacta International201311—
+1K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113—
+1K092765Lanx Anterior Plating SystemLanx, Inc.20101—
+1K082187Biomet Anterior Lumbar PlateEbi, L.P.2008126—
+1K081568Antegra-TSynthes Spine Co.Lp2008472—
+1K080020ArcofixSynthes Spine Co.Lp20080—
+1K073437Thor Anterior Plating SystemStryker Spine200810231
+1K070922Modification to Spinal Usa VBR SystemSpinal USA2007161—
+1K062836Citadel Anterior Lumbar Plate SystemGlobus Medical, Inc.200650—
+1K063158Synthes Antegra SystemSynthes Spine Co.Lp2006477—
+1K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006165—
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+2K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+2K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+2K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+2K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210—
+2K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+2K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation202012—
+2K201136Cure™ Lumbar Plate SystemMeditech Spine, LLC20200—
+2K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+2K190016Lateral Plate SystemCorelink, LLC201915—
+2K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd.20190—
+2K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc.20184—
+2K180090Cure™ Lumbar Plate SystemMeditech Spine, LLC20181—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K162824Z-Span Plate SystemZavation, LLC20172—
+2K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K160362Z-Span Plate SystemZavation, LLC20163—
+2K142699LITe Plate SystemStryker Corporation201446—
+2K121815Nuvasive Sage Lateral Plate SystemNuvasive, Inc.2012469—
+2K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113—
+2K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009159—
+2K090222Pioneer Lumbar Plate SystemPioneer Surgical Technology20093—
+2K080773Thor Anterior Plating SystemStryker Spine2008101—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—
+3K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K202624Z-Span Plate SystemZavation Medical Products, LLC20201—
+3K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+3K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K182808Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc.20181—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+3K150449LITe Plate SystemStryker Corp.201524—
+3K131723Coroent Single Tab SystemNuvasive, Inc.2013466—
+3K130868Nuvasive Decade Lateral Plate SystemNuvasive, Inc.201319—
+3K121323Medicrea International Anterior Lumbar PlateMedicrea International20120—
+3K120724Pioneer Lateral Plate SystemPioneer Surgical Technology, Inc.20120—
+3K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+4K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—