510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K200312Tryptik TiSpineart20202—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+5K193521Steerable Plateau TiLife Spine, Inc.20201—
+5K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+5K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+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—
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+5K190544XIHPOS™ ZFUZE™ Interbody Fusion SystemDifusion Technologies20190—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K1803473d CageFims Co., Ltd.20190—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC20190—
+5K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+5K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K191423Normandy VBR SystemZavation Medical Products, LLC20193—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+5K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+5K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+5K190618RIGEL PEEK Anterior Cervical Interbody Fusion SystemMiRus, LLC20191—
+5K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+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—
+5K183510T2 STRATOSPHERE Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc.201927—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+5K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K182584Lucent® XPSpinal Elements, Inc.20183—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181818Scarlet AL-TSpineart201864—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+5K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+5K181295Genesys Spine AIS-C Cervical Stand-Alone SystemGenesys Spine201817—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+5K173947Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC201801
+5K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+5K180695FBC 921 (Alif)Fbc Device Aps20180—
+5K180401TiWAVE-C™ Porous Titanium Cervical CageKalitec Direct, LLC20185—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+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—
+5K172320Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc.20183—
+5K172941CASCADIA Interbody SystemK2m201852—
+5K171312FortiCore®Nanovis, LLC20183—
+5K172696FORZA® XP Expandable Spacer SystemOrthofix, Inc.201825—
+5K172330Blustone Synergy Silica SystemBlustone Synergy20170—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+5K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+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—
+5K171633NuVasive TLX Interbody SystemNu Vasive, Incorporated2017251—
+5K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+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—
+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—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+5K170676HD Lumbar Interbody SystemHd Lifesciences, LLC2017122—