510(k) Report

Devices descending from K033510

25 later devices reach Modification to Telegraph Humeral Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie20200—
+1K052058Modification to: Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie20050—
+1K042332Titanium Telegraph Humeral NailFournitures Hospitalieres Industrie200424—
+2K082754Aequalis Humeral Nail SystemTornier2009222
+3K133376Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightTornier, Inc.20133—
+3K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa)2011172
+4K252016Arthrex Humeral NailsArthrex, Inc.20260—
+4K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc.20231—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC201215—
+5K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH20250—
+5K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+5K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+6K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+6K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+6K210792Auxein Nailing SystemAuxein Medical Private Limited20210—
+6K170972Apex Tibial Nailing SystemOrthoxel20171—
+6K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+6K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+7K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+7K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+7K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+8K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+8K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+8K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—