510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182885Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™…Medtronic Sofamor Danek USA, Inc.20198—
+7K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS®…Globus Medical, Inc.20192—
+7K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+7K181118Reliance Lumbar IBF SystemReliance Medical Systems20190—
+7K182210TiWAVE-L Porous Titanium Lumbar CageKalitec Medical, LLC20193—
+7K181589Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC20186—
+7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated201841—
+7K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc.2018110—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K181140Axis Chena Cervical PEEK Spacer SystemAxis Orthopaedics20182—
+7K181963ostaPek Interbody Fusion CagesColigne AG20181—
+7K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+7K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNeurostructures, Inc.20180—
+7K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+7K181397DualXInnovasive, Inc.201815—
+7K181980OsseoScrew SystemAlphatec Spine, Inc.20181—
+7K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+7K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+7K181337Sypher Spacer SystemBiogennix, LLC20180—
+7K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+7K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+7K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+7K181347Aries® Lumbar InterbodiesOsseus Fusion Systems, LLC201824—
+7K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+7K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+7K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201841—
+7K181115CxHA PEEK Cervical IBF SystemInnovasis, Inc.20188—
+7K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+7K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+7K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+7K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+7K181203Juliet TiSpineart20181—
+7K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC2018106—
+7K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation20181—
+7K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+7K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+7K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+7K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+7K180480ATEC Universal Spacer SystemAlphatec Spine, Inc.2018113—
+7K172480icotec Interbody Cage SystemIcotec AG20185—
+7K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+7K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+7K172484A-CIFT SoloFuseSpinefrontier, Inc.201871
+7K172568CervagePrecifit Medical, Ltd.20181—
+7K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+7K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+7K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—
+7K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+7K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+7K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+7K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF SystemInnovasis, Inc.2018551
+7K180324Patriot Spinal Fixation SystemValorus Spine20180—
+7K180210CREO® Stabilization SystemGlobus Medical, Inc.201888—
+7K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw…Globus Medical, Inc.20184—
+7K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+7K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc.20180—
+7K172115Navigated Instrument SystemOrthofix, Inc.20184—
+7K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+7K173077Cavetto-SA Cervical Cage SystemNeurostructures, Inc.201821—
+7K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+7K172816TiGer Shark™ SystemChoicespine, LP201859—
+7K171312FortiCore®Nanovis, LLC20183—
+7K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation20181—
+7K173508Everest Spinal SystemK2m20189—
+7K172518Spineology Navigation InstrumentsSpineology, Inc.20184—
+7K173702Juliet Ti LLSpineart20182—
+7K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+7K172676NuVasive® Modulus-C Interbody SystemNu Vasive, Incorporated2017125—
+7K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+7K172756Varian cageMedyssey USA, Inc.20171—
+7K173126Arisstos™ Spinal SystemIngenium Spine20171—
+7K172419Velofix™ TLIF CageU&I Corporation20172—
+7K172469TiLock Modular Spinal SystemGenesys Spine20170—
+7K172424Velofix™ SA Cervical CageU&I Corporation201751
+7K172083Idys™ ALIF SystemClariance, Sas20177—
+7K172446SPIRA-C Open Matrix Cervical InterbodyCamber Spine Technologies20176—
+7K172392Lateral Spinal Truss System (LSTS) Interbody Fusion Device4Web, Inc.20171—
+7K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer SystemOrthofix, Inc.2017143
+7K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+7K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic201764—
+7K172065Scarlet AC-TSpineart20172—
+7K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+7K172587Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markersMedacta International S.A.20170—
+7K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+7K171496Tritanium C Anterior Cervical CageStryker Spine2017129—
+7K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+7K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+7K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+7K170851Anterior Spine Truss System (STS) Interbody Fusion Device4Web, Inc.20175—
+7K171758M.U.S.T. Combined Set ScrewsMedacta International S.A.20177—
+7K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+7K170550Coveris Cervical Cage SystemCamber Spine Technologies20171—
+7K170318NeoFuse Ti3D PLIF/TLIF/Cervical InterbodyHt Medical, LLC201749—
+7K170503EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular…Eit Emerging Implant Technologies GmbH20171992
+7K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+7K171170M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional ScrewsMedacta International S.A.201723—
+7K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+7K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—