510(k) Report

Devices descending from K033109

1,218 later devices reach Ellys and Aurys Vertebral Body Replacements through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+5K201287Impulse Interbody Fusion SystemDegen Medical20208—
+5K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+5K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+5K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+5K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+5K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+5K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+5K200115Cavetto-SA Cervical Cage SystemNeurostructures, Inc.202019—
+5K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+5K201585Monterey AL Interbody SystemStryker Corporation202044
+5K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+5K200541Hive™ Stand-alone Anterior Lumbar Interbody SystemHd Lifesciences, LLC20201—
+5K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+5K200312Tryptik TiSpineart20202—
+5K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+5K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+5K192897icotec Cervical CageIcotec AG20201—
+5K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+5K192497EVOL ha - D Lateral Interbody Fusion SystemCutting Edge Spine, LLC20201—
+5K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+5K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+5K192208CORNICE Cervical Spacer SystemLegend Spine Technologies20190—
+5K191243HEDRON Cervical SpacersGlobus Medical, Inc.201936—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc.20191024
+5K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+5K190885Elevation Spine Saber-C SystemElevation Spine201925—
+5K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+5K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+5K183092Kuros TLIF CageKuros Biosciences B.V20190—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K190322SCARLET® AC-T Secured Anterior Cervical CageSpineart20191—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+5K183447EIT Cellular Titanium Lumbar Cage - T/PLIFEit Emerging Implant Technologies GmbH2019131—
+5K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+5K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+5K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+5K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine20194—
+5K180909REVEL SpacersGlobus Medical, Inc.201837—
+5K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+5K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+5K182322Duo Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+5K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+5K173893TrabisColigne AG20180—
+5K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+5K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+5K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+5K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+5K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+5K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+5K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+5K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+5K180642Pro-Link® Ti Stand-Alone Cervical Spacer SystemLife Spine, Inc.20182—
+5K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+5K172568CervagePrecifit Medical, Ltd.20181—
+5K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+5K173535Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody…Titan Spine, LLC20181052
+5K172941CASCADIA Interbody SystemK2m201852—
+5K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+5K173508Everest Spinal SystemK2m20189—
+5K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+5K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+5K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+5K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+5K173182ProLift® Expandable SystemLife Spine, Inc.201737—
+5K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+5K172465Idys™ TLIF 3DTi CagesClariance, Sas20176—
+5K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH2017159—
+5K172009Cascadia Interbody SystemK2m, Inc.2017433
+5K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+5K163595IMPIX 3D Print CagesMedicrea International SA2017282
+5K162315FORTIFY Corpectomy SpacersGlobus Medical, Inc.201755—
+5K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+5K172341NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated2017163—
+5K171489Acapella Cervical Spacer SystemChoicespine, LP201739—
+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—
+5K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+5K172064Ti-Diagon Oblique TLIFCamber Spine Technologies201727—
+5K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+5K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+5K170888Renovis S141 Lumbar Interbody Fusion SystemRenovis Surgical Technologies20175—
+5K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+5K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+5K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+5K170569SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation201782—
+5K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+5K170953Tomcat Cervical Spinal SystemChoicespine, LP2017103—