510(k) Report

Devices descending from K010780

168 later devices reach Trochanteric Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181184OIC Intramedullary Nail SystemThe Orthopaedic Implant Company20181—
+4K181375Apex Femoral Nailing SystemOrthoxel20180—
+4K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws…Stryker Trauma GmbH201816—
+4K150867Affixus Tibial Nailing SystemBiomet, Inc.20153—
+4K143321ITST Intertrochanteric/Subtrochanteric Fixation SystemZimmer, Inc.201502
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K120715Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia ShortZimmer GmbH201210—
+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—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH20250—
+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—
+5K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company20230—
+5K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+5K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH20201—
+5K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws…Stryker Trauma GmbH201915—
+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—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+6K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+6K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+6K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+6K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+6K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+6K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+6K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon…Stryker GmbH202011—
+6K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH20204—
+6K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+6K173746Activmotion RangeNewclip Technics20181—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+6K163589SIGN IM NailSign Fracture Care International20170—
+6K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+6K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+7K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+7K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+7K241539Activmotion SNewclip Technics20240—
+7K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+7K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+8K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—