510(k) Report

Devices descending from K003043

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+7K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+7K152539SpineView X-Pac Expandable Lumbar Cage SystemSpine View, Inc.20166—
+7K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+7K152304Tritanium PL CageStryker20154481
+7K151727Everest Spinal SystemK2m, Inc.201511—
+7K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+7K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+7K150321EVOS Lumbar Interbody SystemCutting Edge Spine, LLC201592—
+7K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+7K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+7K143616AccuLIF TL and PL CageStryker Corporation20154694
+7K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+7K142360Everest Spinal SystemK2m, Inc.201522—
+7K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+7K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+7K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+7K142277Juliet POSpineart2014119—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K141147Range Spinal SystemK2m, Inc.20141—
+7K140474Juliet OLSpineart2014120—
+7K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+7K133583Opticage Interbody Fusion Device, Model Series 9070Interventional Spine, Inc.20140—
+7K132559Monument SpacersGlobus Medical, Inc.2013166—
+7K133650Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2013344—
+7K132897Clydesdale Spinal SystemMedtronic Sofamor Danek, Inc.2013279—
+7K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+7K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+7K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+7K130194Acculif XL CageCoalign Innovations, Inc.20131—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+7K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+7K121683Acculif TL CageCoalign Innovations, Inc.2012682—
+7K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+7K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—
+7K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+7K100820Wenzel Spine Varilift Interbody Fusion SystemWenzel Spine201016—
+7K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+7K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+7K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20087751
+7K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008840—
+7K073291Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.20081,103—
+7K080083Intrepid Spinal SystemMedtronic Sofamor Danek20089328
+7K073502Vertebron VBR SystemVertebron, Inc.200812—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+8K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+8K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+8K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+8K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+8K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+8K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+8K253331PressON Spinal Fixation SystemNexus Spine20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243474MagnetOs MISKuros Biosciences B.V20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+8K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+8K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K233084Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Gbs Commonwealth Co., Ltd.20232—
+8K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+8K223776PEEK Spinal Infusion CageChangzhou Geasure Medical Apparatus and Instruments Co., Ltd.20230—
+8K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+8K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220449DePuy CONDUIT LLIF SQUID InserterEnztec Limited20220—
+8K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+8K212823DePuy CONDUIT LLIF Angled InsertersEnztec Limited20213—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+8K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—