510(k) Report

Devices descending from K103034

137 later devices reach Genesys Spine Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+1K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+1K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+1K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+1K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+1K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+1K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+1K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+1K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+1K150812Genesys Spine Apache Cervical Interbody Fusion SystemGenesys Spine201512—
+1K141798Sypher Spacer SystemBiogennix, LLC20151—
+1K142328nvcNvision Biomedical Technologies, LLC20144—
+1K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+1K141129Exactech Cervical Spacer SystemExactech, Inc.20148—
+1K130913Genesys Spine Apache Lateral Lumbar Interbody Fusion SystemGenesys Spine201314—
+1K130317Genesys Spine Apache Ibfd Star Cervical SystemGenesys Spine20139—
+1K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+1K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+1K120401Alamo TAlliance Partners, LLC20121—
+1K120966Depuy Pulse Lumbar Cage SystemMedos International SARL201225—
+1K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+1K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+2K241846E3D™-C Interbody SystemEvolution Spine20246—
+2K240368E3D™-A Interbody SystemEvolution Spine20247—
+2K232432E3D™-A Interbody SystemEvolution Spine20248—
+2K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+2K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+2K231704Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer SystemLife Spine, Inc.20230—
+2K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+2K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+2K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+2K1803473d CageFims Co., Ltd.20190—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K190380nvcNvision Biomedical Technologies, Inc.20193—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181397DualXInnovasive, Inc.201815—
+2K181337Sypher Spacer SystemBiogennix, LLC20180—
+2K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+2K140303Alamo TAlliance Partners, LLC20140—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+2K131671MectalifMedacta International201322—
+2K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+3K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+3K262094E3D™-C Interbody SystemEvolution Spine20260—
+3K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K260038E3D™-C Interbody SystemEvolution Spine20261—
+3K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+3K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K221844TDM Lumbar Interbody Fusion Cage SystemTdm Co., Ltd.20221—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203444BEE HA CageNGMedical GmbH20211—
+3K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K172424Velofix™ SA Cervical CageU&I Corporation201751
+3K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+3K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+3K133192Mectalif TipeekMedacta International201416—
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K250560BEE HANGMedical GmbH20250—
+4K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+4K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+4K240699SCARLET® AC-TiSpineart SA20240—