510(k) Report

Devices descending from K010801

91 later devices reach T2 Femoral 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—
+1K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+1K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+1K112059T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpStryker201110—
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+1K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+1K101438T2 Greater Trochanter NailHowmedica Osteonics Corp.2010252
+1K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+1K043270Sirus Intramedullary Nail-Femoral and Tibial Nails, Models 02.02631, 02.02651, 02.02652…Zimmer GmbH2005532
+1K022632Sign IM NailSurgical Implant Generation Network (Sign)20022—
+1K021782BNFAap Implantate AG20020—
+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—
+2K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+2K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+2K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments SystemStryker Trauma GmbH201817—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K163589SIGN IM NailSign Fracture Care International20170—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K152757SIGN Hip Construct (SHC)Sign Fracture Care International20150—
+2K152295Talon DistalFix Antegrade/Retrograde Femoral NailOrthopedic Designs North America, Inc.20150—
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K150655OIC Intramedullary Nail SystemOrthopaedic Implant Company20152—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K123745SP2 Femoral Locking Nail, SP2 Tibial Locking NailBiomecanica Industria E Comerico DE Productos Orto20130—
+2K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K090596Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis Fossa and…Zimmer, Inc.2009316
+2K083497Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral NailsZimmer, Inc.20093916
+2K082770Zimmer Natural Nail System Tibial NailZimmer, Inc.20083515
+2K080706Connexx Locking Tibia NailI.T.S. Implantat-Technologie-Systeme GmbH200811—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+3K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+3K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+3K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+3K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+3K230512Gamma4 SystemStryker GmbH20230—
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+3K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K172114Zimmer Natural Nail SystemZimmer, Inc.201711—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K130595Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc.201323
+3K091566Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH2009165
+4K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH20234—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K200869Gamma3 SystemStryker Trauma GmbH20209—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K192312Zimmer Natural Nail System Cephalomedullary NailsZimmer GmbH20194—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K181375Apex Femoral Nailing SystemOrthoxel20180—
+4K140601Flow-NailFlow-Fx, LLC20142—
+4K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+5K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+5K221115Flow-NailFlow-Fx, LLC20221—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K234075Flow-NailFlow-Fx, LLC20240—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123