510(k) Report

Devices descending from K083815

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+1K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+1K103666Lanx LateralLanx, Inc.2011238—
+1K103660Lanx Cervical Intervertebral Body Fusion SystemLanx, Inc.201141—
+1K102738Lanx Fusion SystemLanx, LLC20113281
+1K092774Atlas Intervertebral Body CageSpinal Edge, LLC20100—
+2K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+2K181655Renovis S180 Lateral Lumbar Interbody Fusion SystemRenovis Surgical Technologies20184—
+2K180695FBC 921 (Alif)Fbc Device Aps20180—
+2K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K170235Lucent®Spinal Elements, Inc.2017107—
+2K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+2K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+2K141135Juliet LLSpineart2014146—
+2K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+2K123767Lanx Fusion System- SALanx, Inc.20133244
+2K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+3K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+3K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+3K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+3K190055Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20191—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+3K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K172941CASCADIA Interbody SystemK2m201852—
+3K173702Juliet Ti LLSpineart20182—
+3K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K161888JULIET® LL Lateral Lumbar CageSpineart2016145—
+3K152622Alta ACDF SystemBiomet Spine20160—
+3K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+3K141791Biomet Fusion SystemBiomet Spine2014128—
+3K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+3K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K131540Interfuse L Intervertebral Body Fusion DeviceVertebral Technologies, Inc.20136—
+3K131547Lanx Fusion SystemLanx, Inc.20131631
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K242303MOD-COrthomod, LLC20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+4K234150Lucent® XPSpinal Elements20240—
+4K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationMiRus, LLC20230—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K223510Matrix HA Fusion Porous Cervical IBF SystemInnovasis, Inc.20220—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K220875HAcancellous PEEK-C Porous HA PEEK Cervical IBF SystemInnovasis, Inc.20224—
+4K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+4K201671A-Link ZAcuity Surgical Devices, LLC202125—
+4K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+4K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+4K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+4K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+4K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+4K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+4K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+4K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+4K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+4K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+4K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+4K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+4K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+4K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+4K181644EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH2018141—