510(k) Report

Devices descending from K103002

17 later devices reach Synthes Multiloc Proximal Humeral Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252016Arthrex Humeral NailsArthrex, Inc.20260—
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+2K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+3K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+3K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+3K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—