510(k) Report

Devices descending from K013524

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+7K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+7K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+7K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+8K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+8K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+8K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+9K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+9K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+9K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+10K261481Pangea Femur Reconstruction SystemStryker GmbH20260—