510(k) Report

Devices descending from K131547

163 later devices reach Lanx Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+1K172941CASCADIA Interbody SystemK2m201852—
+1K141791Biomet Fusion SystemBiomet Spine2014128—
+2K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+2K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+2K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+2K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+2K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+2K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+2K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+3K253545Vulcan Spinal SystemK2m, Inc.20260—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+3K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+3K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+4K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+4K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+4K211306LabyrinthZavation Medical Products, LLC20213—
+4K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+4K200969NEXXT MATRIXX SystemNexxt Spine, LLC20200—
+4K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+4K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+4K183092Kuros TLIF CageKuros Biosciences B.V20190—
+4K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+4K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+4K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+5K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+5K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+5K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+5K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+5K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+5K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+5K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—