510(k) Report

Devices descending from K061019

60 later devices reach Trigen Meta-Nail Retrograde Femoral and Tibial Nails through their predicates, nearest generation first.

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