510(k) Report

Devices descending from K102738

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+1K180695FBC 921 (Alif)Fbc Device Aps20180—
+1K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+1K123767Lanx Fusion System- SALanx, Inc.20133244
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+2K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+2K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+2K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+2K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+2K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K172941CASCADIA Interbody SystemK2m201852—
+2K133827A-Link ZOsteo Vasive, LLC2014262
+2K141791Biomet Fusion SystemBiomet Spine2014128—
+2K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+2K131547Lanx Fusion SystemLanx, Inc.20131631
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+3K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+3K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+3K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+3K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+3K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+4K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+4K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+4K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+4K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+4K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+4K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+4K181818Scarlet AL-TSpineart201864—
+4K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+4K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+4K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—