510(k) Report

Devices descending from K061229

165 later devices reach Unity LX Anterolateral Lumbar Plate Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+1K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113—
+1K092765Lanx Anterior Plating SystemLanx, Inc.20101—
+1K070922Modification to Spinal Usa VBR SystemSpinal USA2007161—
+2K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210—
+2K202309Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero…Zimmer Biomet Spine, Inc.20200—
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K182808Aspida® Anterior Lumbar Plating SystemAlphatec Spine, Inc.20181—
+2K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+2K121323Medicrea International Anterior Lumbar PlateMedicrea International20120—
+2K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009159—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K190016Lateral Plate SystemCorelink, LLC201915—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+3K142699LITe Plate SystemStryker Corporation201446—
+3K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+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—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233360Curiteva Thoracolumbar Plate SystemCuriteva, Inc.20240—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+4K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+4K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+4K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+4K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+4K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc.20219—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K201287Impulse Interbody Fusion SystemDegen Medical20208—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+4K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+4K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC20200—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.202013—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K192678Genesys Spine Binary® Lumbar Plate SystemGenesys Spine20191—
+4K190584CAYMAN LP Plate SystemK2m, Inc.20192—
+4K183214Raven Lumbar Plate SystemChoicespine, LP20192—
+4K150449LITe Plate SystemStryker Corp.201524—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K241175MiRus MoRe Lumbar Plating SystemMiRus, LLC20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—