510(k) Report

Devices descending from K073291

1,103 later devices reach Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K162693VertebraLINK Fusion PlatformFacetlink Dba Linkspine20170—
+2K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+2K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion SystemGenesys Spine201611—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K153621Juliet® TiSpineart2016751
+2K160631Keos Lumbar IBFDKeos20161—
+2K153436LATERAL Spine Truss System4Web, Inc.20165—
+2K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+2K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K160418PERIMETER Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.20165—
+2K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+2K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+2K150847Foundation Interbody DevicesCorelink, LLC201529—
+2K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+2K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC20156—
+2K140348Interbody CageEisertech, LLC2015235—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+2K142277Juliet POSpineart2014119—
+2K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+2K140303Alamo TAlliance Partners, LLC20140—
+2K140474Juliet OLSpineart2014120—
+2K132738Cogent Med-LifCogent Spine, LLC201413—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K133893Sterispine LC CageSafe Orthopaedics20141—
+2K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K133192Mectalif TipeekMedacta International201416—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K133216Crescent Spinal SystemMedtronic Sofamor Danek, Inc.201392—
+2K131178Idys Lif CagesClariance201311—
+2K132700Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek, Inc.2013170—
+2K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+2K124034Mectalif AnteriorMedacta International201311—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K112700Frontier Sadl Interbody Fusion DeviceFrontier Medical Devices, Inc.20121—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+2K122591Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.201214—
+2K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated2012172—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+2K112862Mecta-CMedacta International201114—
+2K112405Clydesdales Spinal SystemMedtronic Sofamor Danek USA, Inc.2011296—
+2K111525Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2011355—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+3K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+3K252742Navigated InstrumentsTyber Medical, LLC20251—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+3K243670Idys® LIFClariance20240—
+3K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+3K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+3K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+3K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—