510(k) Report

Devices descending from K153649

5 later devices reach Exactech® Novation® Element Press-fit Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171249Entrada™ hip stemOrtho Development Corporation20172—
+1K162732Exactech® Alteon® HA Femoral StemExactech, Inc.201711
+2K243839Alteon® HA Femoral StemsExactech, Inc.20250—
+2K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+3K251052Trivicta® Hip StemOrtho Development Corp.20250—