510(k) Report

Devices descending from K062759

1,406 later devices reach Paramount VBR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.20071,405—
+2K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+2K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+2K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+2K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+2K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+2K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+2K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+2K073502Vertebron VBR SystemVertebron, Inc.200812—
+3K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+3K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191796Neo Cage SystemNeo Medical SA20190—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+3K181048Neo Cage System TMNeo Medical SA20191—
+3K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+3K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+3K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+3K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+3K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2017109—
+3K171107CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.20178—
+3K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+3K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K151481Sahara Stabilization SystemK2m, Inc.20155—
+3K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+3K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+3K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+3K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+3K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+3K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+3K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+3K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+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—
+3K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+3K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+3K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+3K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+3K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+3K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+3K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+3K131671MectalifMedacta International201322—
+3K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+3K122047Alamo PAlliance Partners, LLC20120—
+3K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+3K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+3K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+3K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+3K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+3K113478Plif CageEisertech, LLC2012269—
+3K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+3K112862Mecta-CMedacta International201114—
+3K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+3K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+3K111569Plateau Spacer SystemLife Spine2011181—
+3K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+3K110927MectalifMedacta International2011301
+3K103111Forza Spacer SystemOrthofix, Inc.20113431
+3K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+3K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+3K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+3K082801Phantom Plus Cage SystemUs Spine2008643—
+3K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+3K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K260810Anteralign LS coverplateTyber Medical, LLC20260—
+4K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+4K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251016MectaLIF 3D MetalMedacta International S.A.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+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—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—