510(k) Report

Devices descending from K100238

7 later devices reach HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192003Auxein Nailing SystemAuxein Medical Private Limited20202—
+1K183162Affixus Hip Fracture NailBiomet, Inc.20182—
+1K111444Universal and Troch Entry Femoral Nailing Systems Line ExtensionDePuy Orthopaedics, Inc.20110—
+2K230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail…Tdm Co., Ltd.20240—
+2K233910Vertex Hip Fracture Nailing SystemOrthoxel Dac20240—
+2K221489Artemis Proximal Femoral Nail SystemGlw, Inc.20220—
+2K210792Auxein Nailing SystemAuxein Medical Private Limited20210—