510(k) Report

Devices descending from K040212

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K173746Activmotion RangeNewclip Technics20181—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+5K163589SIGN IM NailSign Fracture Care International20170—
+5K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated20151—
+5K141103Intramedullary Nail and Screws-NeonailNeoortho Produtos Ortopedicos S/A20141—
+6K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+6K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+6K241539Activmotion SNewclip Technics20240—
+6K230088Ankle Truss System (ATS)4Web Medical, Inc.20241—
+6K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+6K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH20217—
+6K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+6K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated20150—
+7K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+7K242356TIDAL Fusion Cage SystemRestor3D, Inc.20250—
+7K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+8K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+8K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+8K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+9K261481Pangea Femur Reconstruction SystemStryker GmbH20260—