510(k) Report

Devices descending from K020522

1,234 later devices reach Modification to Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+5K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+5K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+5K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K192760NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated2019163—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191537eCarbon IBDsBack 2 Basics Direct, LLC20193—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+5K191408Nexxt Matrixx SystemNexxt Spine, LLC20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183049Reliance Lumbar IBF SystemReliance Medical Systems, LLC20197—
+5K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+5K182477Cervical SpacerAdditive Implants, LLC201915—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201828—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+5K180673Normandy VBR SystemZavation Medical Products, LLC20187—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+5K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+5K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+5K173892NuVasive® XLX Interbody SystemNu Vasive, Incorporated2018115—
+5K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+5K180056Genesys Spine AIS-C Cervical Anchored Interbody SystemGenesys Spine201818—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K171312FortiCore®Nanovis, LLC20183—
+5K173283Reliance Lumbar IBF SystemReliance Medical Systems, LLC20189—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K170389TAURUS PEEK Cage SystemMedyssey USA, Inc.20170—
+5K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+5K172419Velofix™ TLIF CageU&I Corporation20172—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+5K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated2017227—
+5K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+5K172065Scarlet AC-TSpineart20172—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+5K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+5K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+5K171351Posterior Spine Truss System (PSTS) Interbody Fusion Device4Web, Inc.20177—
+5K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+5K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+5K171140Matrixx SystemNexxt Spine, LLC2017145—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+5K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+5K170961NuVasive CoRoent Small Interlock II SystemNu Vasive, Incorporated201718—
+5K162496Foundation 3D InterbodyCorelink, LLC201782—
+5K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—
+5K163364MOJAVE Expandable Interbody SystemK2m201725—
+5K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—