510(k) Report

Devices descending from K152439

3 later devices reach U2 Bipolar Implant and 22mm Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+1K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—