510(k) Report

Devices descending from K072120

1,405 later devices reach Paramount Intervertebral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+1K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+1K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+1K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+1K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+1K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+1K073502Vertebron VBR SystemVertebron, Inc.200812—
+2K242267Gemini Medical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20241—
+2K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+2K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+2K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+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—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K191796Neo Cage SystemNeo Medical SA20190—
+2K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+2K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+2K181048Neo Cage System TMNeo Medical SA20191—
+2K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+2K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+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—
+2K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+2K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201711—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+2K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+2K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+2K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+2K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+2K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+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—
+2K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+2K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+2K131981Cezanne II Interbody Fusion SystemAccel Spine201354
+2K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+2K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+2K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+2K131671MectalifMedacta International201322—
+2K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+2K122047Alamo PAlliance Partners, LLC20120—
+2K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+2K121569Matisse Anterior Cervical Interbody Fusion Cage SystemAccel Spine20123—
+2K120840Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201214—
+2K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+2K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+2K113478Plif CageEisertech, LLC2012269—
+2K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+2K112862Mecta-CMedacta International201114—
+2K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+2K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+2K111569Plateau Spacer SystemLife Spine2011181—
+2K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+2K110927MectalifMedacta International2011301
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+2K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+2K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+2K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+2K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+2K082801Phantom Plus Cage SystemUs Spine2008643—
+2K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+2K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260810Anteralign LS coverplateTyber Medical, LLC20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+3K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—