510(k) Report

Devices descending from K082754

22 later devices reach Aequalis Humeral Nail System through their predicates, nearest generation first.

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