510(k) Report

Devices descending from K082342

716 later devices reach Modification to Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+1K191796Neo Cage SystemNeo Medical SA20190—
+1K181048Neo Cage System TMNeo Medical SA20191—
+1K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+1K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+1K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+2K183243Velofix TLIF CageU&I Corporation20190—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K171749Velofix (tm) Interbody Fusion SystemU&I Corporation20175—
+2K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K201793EDEN Peek CageJmt Co., Ltd.20210—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+3K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K143616AccuLIF TL and PL CageStryker Corporation20154694
+3K141896Coroent SystemNu Vasive, Incorporated2014480—
+3K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+3K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+4K223494CD Horizon Spinal SystemMedtronic202317—
+4K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+4K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+4K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+4K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+4K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+4K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+4K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+4K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+4K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+4K181096Avenue P Cage SystemZimmer Biomet Spine, Inc.20190—
+4K181899Roccia® PlifSilony Medical GmbH20180—
+4K180590Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20186—
+4K173787X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Medos International SARL20182—
+4K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+4K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+4K170235Lucent®Spinal Elements, Inc.2017107—
+4K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+4K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+4K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+4K162212Divergence-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.201757—
+4K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+4K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+4K161230NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated2016381—
+4K153621Juliet® TiSpineart2016751
+4K153438PERIMETER C (Titanium) Spinal SystemMedtronic Sofamor Danek USA, Inc.20160—
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K152304Tritanium PL CageStryker20154481
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+4K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+5K261049Scala® TLSpineart SA20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240368E3D™-A Interbody SystemEvolution Spine20247—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+5K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+5K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371