510(k) Report

Devices descending from K172651

3 later devices reach FMP Extended Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+1K190057DJO Acetabular SystemEncore Medical L.P.201925
+2K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—