510(k) Report

Devices descending from K073291

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+1K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+1K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+1K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+1K201287Impulse Interbody Fusion SystemDegen Medical20208—
+1K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+1K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+1K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+1K191796Neo Cage SystemNeo Medical SA20190—
+1K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+1K181048Neo Cage System TMNeo Medical SA20191—
+1K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+1K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+1K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+1K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+1K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+1K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+1K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+1K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+1K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+1K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+1K131671MectalifMedacta International201322—
+1K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+1K122047Alamo PAlliance Partners, LLC20120—
+1K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+1K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+1K113478Plif CageEisertech, LLC2012269—
+1K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+1K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+1K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+1K111569Plateau Spacer SystemLife Spine2011181—
+1K110927MectalifMedacta International2011301
+1K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+1K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+1K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+1K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+1K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+2K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K260810Anteralign LS coverplateTyber Medical, LLC20260—
+2K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+2K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+2K251016MectaLIF 3D MetalMedacta International S.A.20250—
+2K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+2K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+2K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+2K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+2K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+2K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+2K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+2K213417Ghost Spacer SystemLife Spine, Inc.20220—
+2K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+2K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+2K212831MectaLIF ExtensionMedacta International S.A.20211—
+2K211689KEYSTONE PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20212—
+2K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+2K211442StealthStation Spinous Process ClampsMedtronic Navigation20212—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K200551MectaLIF Transforaminal TiPEEKMedacta Inernational SA20214—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+2K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K182987Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20199—
+2K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+2K191039Navigated T2 STRATOSPHERE Inserters and Navigated TemplatesMedtronic Sofamor Danek USA, Inc.201918—
+2K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181625Life Spine Resolute™ Threaded Cage SystemLife Spine, Inc.20180—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K182470Plateau Spacer SystemLife Spine20180—
+2K180674EVOL® ha-C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20183—
+2K173189Lumfuse TPPrecifit Medical, Ltd.20180—
+2K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20181—
+2K180071STYLO Interbody Fusion DeviceLegend Spine Technologies20180—
+2K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+2K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+2K172828Double Medical Cage SystemDouble Medical Technology, Inc.20181—
+2K172349InFill® Interbody Fusion DevicePinnacle Spine Group, LLC20171—
+2K163595IMPIX 3D Print CagesMedicrea International SA2017282
+2K172328SOVEREIGN™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201730—
+2K171914Cortina™ Lumbar Cage SystemNeurostructures, Inc.20172—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K163422Shanghai Sanyou PEEK Cage SystemShanghai Sanyou Medical Co, Ltd.20173—
+2K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+2K171656Genesys Spine Apache Interbody Fusion SystemGenesys Spine20170—
+2K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+2K171468FUSE Spinal SystemMedtronic Sofamor Danek20170—
+2K163670Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20173—