510(k) Report

Devices descending from K053261

6 later devices reach Orthofix Titanium Nailing Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl20171—
+1K121312Intramedullary Nail SystemWeigao Orthopaedic Device Co., Ltd.20123—
+2K173458ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing SystemOrthofix Srl20170—
+2K132078Metallic Intramedullary Nail SystemTianjin Walkman Biomaterial Co., Ltd.20141—
+2K132428IDEALJiangsu Ideal Medical Science & Technology Co., LT20130—
+3K151062WASTON Metallic Intramedullary Nail SystemChangzhou Waston Medical Appliance Co., Ltd.20150—