510(k) Report

Devices descending from K072161

22 later devices reach Biomet Femoral Locking Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.20260—
+1K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.2024217
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+1K083726Pedinail Intramedullary Nailing SystemOrthoPediatrics Corp.2009627
+1K081230Trauson Intramedullary NailTrauson (Jiangsu) Medical Instrument Co., Ltd.20090—
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250—
+2K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc.201843
+2K172699Agile NailOrthofix Srl20180—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K250623Pediatric Nailing Platform Tibia Pediatric Nailing Platform FemurOrthoPediatrics Corp.20251—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.20222—
+3K190321Pediatric Nailing PlatformFemurOrthoPediatrics Corp.20190—
+3K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+4K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—