510(k) Report

Devices descending from K103731

907 later devices reach Capstone R Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+1K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+1K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+1K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+1K113642Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA2012292—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+2K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+2K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+2K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion SystemGenesys Spine201610—
+2K153621Juliet® TiSpineart2016751
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K150231Navigated Disc Prep Instruments and CAPSTONE TrialsMedtronic Sofamor Danek USA, Inc.2015242—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K143616AccuLIF TL and PL CageStryker Corporation20154694
+2K141896Coroent SystemNu Vasive, Incorporated2014480—
+2K142277Juliet POSpineart2014119—
+2K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+2K140474Juliet OLSpineart2014120—
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+2K123758Tasmin RSignus Medizintechnik GmbH20141—
+2K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+2K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+2K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+2K131669Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek USA, Inc.2013234—
+2K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+2K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+3K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K223494CD Horizon Spinal SystemMedtronic202317—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+3K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+3K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K200312Tryptik TiSpineart20202—
+3K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+3K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+3K191134IB3D AlifMedicrea International SA20191—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K182158UNiD Patient-matched PLIF cageMedicrea International SA201921—
+3K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+3K190092UNiD Patient specific 3D printed TLIF cageMedicrea International SA201913—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180230NEST Interbody SystemPaonan Biotech Co., Ltd.20191—
+3K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+3K182721Choice Spine Navigation SystemChoicespine, LP20192—
+3K181899Roccia® PlifSilony Medical GmbH20180—
+3K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+3K182470Plateau Spacer SystemLife Spine20180—
+3K181818Scarlet AL-TSpineart201864—
+3K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+3K181203Juliet TiSpineart20181—
+3K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+3K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+3K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+3K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+3K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+3K173782UNiD Patient Specific 3D printed cageMedicrea International SA201823—