510(k) Report

Devices descending from K141791

128 later devices reach Biomet Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+1K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+1K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+1K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+2K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+2K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+2K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+2K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+3K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+3K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+3K183092Kuros TLIF CageKuros Biosciences B.V20190—
+3K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+4K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+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—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+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—
+4K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+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—
+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—
+4K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+4K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+4K191091Rampart One Lumbar Interbody Fusion SystemSpineology, Inc.20191—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+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—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+5K223418DeGen Impulse AM™ SystemDegen Medical20236—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+5K213417Ghost Spacer SystemLife Spine, Inc.20220—
+5K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+5K212358Romero Cervical CageSpineup, Inc.20226—
+5K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+5K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+5K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+5K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—