510(k) Report

Devices descending from K003018

79 later devices reach Titan Tibial Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+1K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+1K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+1K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+1K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company20152—
+1K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+1K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+1K123745SP2 Femoral Locking Nail, SP2 Tibial Locking NailBiomecanica Industria E Comerico DE Productos Orto20130—
+1K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp.2012173
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+1K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+1K011622Osteo IC Femoral and Tibial Nails and Osteo Retrograde/Antegrade Femoral Nails with T2…Howmedica Osteonics Corp.200112—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+2K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+2K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201414—
+2K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201315—
+2K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG201315—
+2K021782BNFAap Implantate AG20020—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+3K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+3K222309Gamma4 SystemStryker GmbH20220—
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K200869Gamma3 SystemStryker Trauma GmbH20209—
+3K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K163589SIGN IM NailSign Fracture Care International20170—
+3K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH2016132
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+4K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+4K161753Hoffman LRF SystemStryker GmbH201612—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K200123Accessories for the SixFix® Hexapod FixatorArrowhead De, LLC20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K163656Hoffmann LRF SystemStryker GmbH2017115
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+6K182968Hoffmann LRF SystemStryker GmbH201910—
+7K203568Hoffmann LRF SystemStryker GmbH20218—
+8K233741Hoffmann LRF SystemStryker GmbH20231—
+8K212895Paragon 28 External Ring Fixation SystemParagon 28, Inc.20215—
+9K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.20250—
+9K253202Hoffmann LRF SystemStryker GmbH20250—
+9K232838Monkey RingsTM External Fixation SystemParagon 28, Inc.20233—
+10K253291Excelsior SystemBlue Ocean Global20260—
+10K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+11K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—