510(k) Report

Devices descending from K040212

121 later devices reach Trigen Intertan through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+1K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.20240—
+1K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.20240—
+1K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+1K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+1K211086The Progen™ Trochanteric Nail SystemOrtho Development Corporation20210—
+1K200869Gamma3 SystemStryker Trauma GmbH20209—
+1K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+1K123948China Nails and AccessoriesSmith & Nephew, Inc.20130—
+1K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+1K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA20123—
+1K092748Sureshot Tan Nails and AccessoriesSmith & Nephew, Inc.201041
+1K080434Intertan CHS Locking Plate System Prox Fem Plates/ScrewSmith & Nephew, Inc.200835—
+1K070761Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod.20083—
+1K051557Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc.200569—
+1K050226Asian Intramedullary Hip Screw NailsSmith & Nephew, Inc.20057—
+1K040656Modification to Smith & Nephew Intramedullary Hip ScrewSmith & Nephew, Inc.20049—
+2K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.20260—
+2K252826ARIX Femur Nail SystemJeil Medical Corporation20250—
+2K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+2K242247ARIX Femur Nail SystemJeil Medical Corporation20251—
+2K243364TRIGEN META-TAN Trochanteric Antegrade NailSmith & Nephew, Inc.20241—
+2K233134I.T.S. INS Proximal Femur NailI.T.S. GmbH20240—
+2K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.20232—
+2K221021Femoral Trochanteric Nail System – NeonailNeoortho Produtos Ortopédicos S/A20220—
+2K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…Smith & Nephew, Inc.202221
+2K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH202231
+2K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc.202171
+2K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+2K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+2K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+2K181640X-BOLT Hip Fracture Fixation SystemX-Bolt Orthopaedics20181—
+2K172830Double Medical Femoral Nail SystemDouble Medical Technology, Inc.20182—
+2K132830Distalock Tibial IM Nail SystemDgimed Ortho, Inc.20140—
+2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.201333—
+2K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+2K083648Gotfried Physiological Hip (PH) NailEfratgo, Ltd. HI Tech Bio-Surgical20090—
+2K061019Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc.2006601
+3K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.20260—
+3K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+3K253517Reselute Tibial NailReselute, Inc.20260—
+3K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+3K253713Arthrex Variable Angle (VA) Proximal Tibia Plating SystemArthrex, Inc.20260—
+3K252019CurvaFix Low Profile SystemCurvafix, Inc.20250—
+3K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+3K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.20250—
+3K243963Pediatric Plating Platform HipOrthoPediatrics Corp.20250—
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K233396Cannulated Screw SystemSmith & Nephew, Inc.20230—
+3K233017TM Plating SystemTyber Medical, LLC20231—
+3K230512Gamma4 SystemStryker GmbH20230—
+3K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+3K222309Gamma4 SystemStryker GmbH20220—
+3K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+3K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+3K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+3K171108AUTOBAHN Nailing SystemGlobus Medical, Inc.20172—
+3K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc.201232
+3K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa)2011181
+3K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+3K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC20091—
+3K070444Aos Tibial NailAdvanced Orthopaedic Solutions, Inc.20074—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K231266Pediatric Nailing Platform TibiaOrthoPediatrics Corp.20232—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K220659AUTOBAHN (R) EVO Femoral NailsGlobus Medical, Inc.20221—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K141447Precice Trauma Nail SystemEllipse Technologies, Inc.20142—
+4K133081Trochanteric Nails and ES Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade…Advanced Orthopaedic Solutions, Inc.20132—
+4K131365T2 Tibial Nailing SystemStryker Trauma AG2013174
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+4K13062512MM and 13MM Tibial NailsAdvanced Orthopaedic Solutions, Inc.20133—
+4K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+4K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+5K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+5K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—