510(k) Report

Devices descending from K052384

455 later devices reach Lanx VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—
+5K181818Scarlet AL-TSpineart201864—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc.20181—
+5K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+5K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+5K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K163543Biomet Fusion SystemZimmer Biomet Spine, Inc.2017124—
+5K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc.20165—
+5K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+5K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+5K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+6K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+6K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+6K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+6K242589Scarlet® AL-TSpineart SA20240—
+6K241846E3D™-C Interbody SystemEvolution Spine20246—
+6K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+6K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+6K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+6K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+6K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—
+6K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+6K230329F3D Interbody SystemCorelink, LLC20230—
+6K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+6K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+6K223868PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.20232—
+6K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+6K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+6K223140AEON-C™ Stand Alone SystemDio Medical, Inc.20222—
+6K222561AlignAcuity Surgical Devices, LLC202214—
+6K221325CONDUIT Lateral Switch PlateMedos International SARL20221—
+6K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+6K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+6K220610SOLO-LAurora Spine, Inc.20220—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+6K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+6K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+6K211474Kleiner KG2 SystemBAAT Medical Products B.V.20210—
+6K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+6K211306LabyrinthZavation Medical Products, LLC20213—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203444BEE HA CageNGMedical GmbH20211—
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+6K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+6K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular…Eit Emerging Implant Technologies GmbH2020130—
+6K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+6K191906MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed…MiRus, LLC20206—
+6K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+6K192993Scarlet AL-TSpineart20201—
+6K192687TrellOss™-L MPFNexxt Spine, LLC20201—
+6K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+6K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+6K181829Velofix TLIF CageU&I Corporation20181—
+6K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K171660Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20174—
+6K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—
+6K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc.20171—
+6K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+7K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K262094E3D™-C Interbody SystemEvolution Spine20260—
+7K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+7K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+7K261067BEE PLIF CageNGMedical GmbH20260—
+7K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+7K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+7K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K250560BEE HANGMedical GmbH20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+7K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+7K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+7K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+7K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+7K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+7K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—