510(k) Report

Devices descending from K051557

69 later devices reach Trigen Retrograde Femoral, Supracondylar and Tibial Nails through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.20232—
+1K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+1K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+1K132830Distalock Tibial IM Nail SystemDgimed Ortho, Inc.20140—
+1K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+1K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.2006601
+2K253517Reselute Tibial NailReselute, Inc.20260—
+2K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+2K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.20240—
+2K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+2K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+2K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+2K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+2K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+2K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+2K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+2K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+2K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+3K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+3K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+3K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+3K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+3K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+3K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+3K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+3K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+3K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+4K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K163589SIGN IM NailSign Fracture Care International20170—
+4K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+4K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+5K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+5K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+5K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+6K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K230512Gamma4 SystemStryker GmbH20230—
+6K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+7K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+7K222309Gamma4 SystemStryker GmbH20220—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+8K261481Pangea Femur Reconstruction SystemStryker GmbH20260—