510(k) Report

Devices descending from K905370

5 later devices reach Exactech Bipolar Hip Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013211Modification to: Acumatch L-Series Bipolar EndoprosthesisExactech, Inc.200141
+2K152439U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation20163—
+3K173455SurgTech Bipolar Head SystemSurgtech, Inc.20180—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—