510(k) Report

Devices descending from K981238

7 later devices reach Bipolar Femoral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050269U1 Hip System - BipolarUnited Orthopedic Corp.20056—
+2K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+2K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+2K101670United U2 Bipolar ImplantUnited Orthopedic Corp.201051
+3K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—