510(k) Report

Devices descending from K043548

211 later devices reach Blackstone Unity Anterior Lumbar Plate Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132589Anterior Lumbar Plate System (Presidio)Life Spine, Inc.201312—
+1K101255Alphatec Spine Anterior Lumbar Plating SystemAlphatec Spine, Inc.2010113—
+1K092765Lanx Anterior Plating SystemLanx, Inc.20101—
+1K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+1K061229Unity LX Anterolateral Lumbar Plate Fixation SystemBlackstone Medical, Inc.2006165—
+2K260015ANTERIS Thoracolumbar Plate SystemSpineCraft20260—
+2K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC20220—
+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—
+2K180166Life Spine Lumbar Fixation System (SENTRY)Life Spine, Inc.20189—
+2K1721312 Hole Lateral Plating SystemLife Spine, Inc.201710—
+2K131533Cayman MI Plate SystemK2m, Inc.201372—
+2K121323Medicrea International Anterior Lumbar PlateMedicrea International20120—
+2K070922Modification to Spinal Usa VBR SystemSpinal USA2007161—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K212937Dakota ALIF Plate SystemPrecision Spine, Inc.20210—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K200956NuVasive Thoracolumbar PlatesNu Vasive, Incorporated20200—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+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—
+3K182473PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate…K2m, Inc.20184—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K162211AccuFit Lateral Plate SystemPrecision Spine, Inc.20164—
+3K091044Spinal Usa Anterior Lumbar Plate SystemSpinal USA2009159—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+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—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+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—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior…Stryker Corporation20221—
+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—
+4K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.20223—
+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—
+4K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+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—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+4K173885Genesys Spine Binary Lumbar Plate SystemGenesys Spine20184—
+4K142699LITe Plate SystemStryker Corporation201446—
+4K121791Zou Anterior Lumbar Plate SystemCorelink, LLC2012113—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+5K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+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—