510(k) Report

Devices descending from K003043

1,819 later devices reach Surgical Titanium Mesh System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K210728CONDUIT InstrumentsMedos International SARL20215—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200552EVOS Lumbar Interbody SystemCutting Edge Spine, LLC20200—
+8K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20203—
+8K192336Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.201917—
+8K192582NuVasive CoRoent Small Interlock SystemNu Vasive, Incorporated201930—
+8K182349Concorde LiftMedos International SARL20190—
+8K190067Velofix Interbody Fusion SystemU&I Corporation20193—
+8K180228II-Type Intervertebral SpacerPaonan Biotech Co., Ltd.20191—
+8K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+8K180502S128 Anterior Lumbar Interbody Fusion (ALIF) SystemRenovis Surgical Technologies, Inc.201811—
+8K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+8K180376K2M Patient Specific RodsK2m, Inc.20182—
+8K173537Concorde Lift™Medos International SARL20181—
+8K173030Vertera Spine Cohere Cervical Interbody Fusion DeviceNu Vasive, Incorporated201722—
+8K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc.20170—
+8K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyRti Surgical, Inc.201710—
+8K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+8K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek2017144—
+8K162262Tritanium® PL CageStryker2016132—
+8K161173Avenue® T TLIF CageLdr Spine USA, Inc.20163—
+8K160856SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20165—
+8K161028K2M Growing Spine SystemK2m, Inc.20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160955Tritanium® PL CageStryker2016178—
+8K153695Biomet Spine Fusion SystemBiomet Spine, LLC201632
+8K152651AccuLIF TL and PL CageStryker Corporation201530—
+8K151900VariLift-L Interbody Fusion DeviceWenzel Spine, Inc.20158—
+8K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+8K151216Everest Spinal SystemK2m, Inc.201511—
+8K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+8K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+8K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+8K141896Coroent SystemNu Vasive, Incorporated2014480—
+8K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K133053Milestone Spinal SystemWeigao Orthopaedic Device Co., Ltd.20142—
+8K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+8K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+8K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+8K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+8K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+8K130274Biolign Acif Systems, Biolign Stacc Acif System, Biolign Tlif SystemElite Surgical Supplies (Pty), Ltd.20139—
+8K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+8K132505Acculif TL and PL CageCoalign Innovations, Inc.20136453
+8K131296Varilift-L Interbody Fusion DeviceWenzel Spine, Inc.20130—
+8K131425Navigated Capstone Trials, Clydesdale Trials, Capstone & Clydesdale InserterMedtronic Navigation, Inc.201324610
+8K131443Coalign Innovations Acculif XL Ibf CageCoalign Innovations, Inc.20130—
+8K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+8K123978Capstone L Spinal SystemMedtronic Sofamor Danek USA201313—
+8K122047Alamo PAlliance Partners, LLC20120—
+8K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+8K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+8K113528Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011361—
+8K110562Telamon Peek Spinal SystemMedtronic Sofamor Danek USA2011306—
+8K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+8K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+8K110543Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc.2011808—
+8K111569Plateau Spacer SystemLife Spine2011181—
+8K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+8K103111Forza Spacer SystemOrthofix, Inc.20113431
+8K100945Fuse Plif CafeAdvanced Medical Technologies AG2011463—
+8K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+8K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+8K100175Clydesdale Spinal SystemMedtronic Sofamor Danek20101,008—
+8K094025Crescent Spinal SystemMedtronic Sofamor Danek2010838—
+8K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+8K090353Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek2009796—
+8K082801Phantom Plus Cage SystemUs Spine2008643—
+8K082732Modification to: Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2008710—
+8K082342Modification to Capstone Spinal SystemMedtronic Sofamor Danek2008716—
+8K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+9K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsMedtronic Navigation, Inc.20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+9K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—