510(k) Report

Devices descending from K013524

132 later devices reach Trochanteric Dyax Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042440Alphatec Femoral Trochanteric Nail (FTN) SystemAlphatec/Nexmed20040—
+1K040212Trigen IntertanSmith & Nephew, Inc.20041216
+1K021008Advanced Orthopaedic Solutions Trochanteric NailAdvanced Orthopaedic Solutions, Inc.20021312
+2K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+2K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.20240—
+2K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.20240—
+2K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+2K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+2K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+2K211086The Progen™ Trochanteric Nail SystemOrtho Development Corporation20210—
+2K202099AOS Galileo™ Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.20204—
+2K200869Gamma3 SystemStryker Trauma GmbH20209—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+2K140601Flow-NailFlow-Fx, LLC20142—
+2K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+2K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K120148Aos Solid Locking Lag Screw, Aos Telescoping Lag ScrewAdvanced Orthopaedic Solutions, Inc.20126—
+2K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA20123—
+2K103533ES Trochanteric Nail, Left and Right, 10MMAdvanced Orthopaedic Solutions, Inc.201111—
+2K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+2K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+2K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+2K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569—
+2K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057—
+2K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049—
+3K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+3K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+3K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+3K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+3K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.20232—
+3K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+3K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+3K221115Flow-NailFlow-Fx, LLC20221—
+3K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+3K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+3K191598AOS ES Retrograde Femoral NailAdvanced Orthopaedic Solutions, Inc.20190—
+3K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+3K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+3K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+3K132830Distalock Tibial IM Nail SystemDgimed Ortho, Inc.20140—
+3K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+3K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+3K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.2006601
+4K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+4K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+4K253517Reselute Tibial NailReselute, Inc.20260—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+4K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+4K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+4K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+4K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+4K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+4K234075Flow-NailFlow-Fx, LLC20240—
+4K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+4K233017TM Plating SystemTyber Medical, LLC20231—
+4K230512Gamma4 SystemStryker GmbH20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K222309Gamma4 SystemStryker GmbH20220—
+4K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+4K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+4K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+4K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+4K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+4K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+4K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+4K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+5K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+5K240487EVOS Patella PlatesSmith & Nephew20240—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+5K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+5K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+5K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+5K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+5K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+5K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+5K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—