510(k) Report

Devices descending from K980513

109 later devices reach Articul/Eze Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+7K181254Quadra PMedacta International S.A.20187—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+8K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+8K202730Quadra-PMedacta International S.A.20201—
+8K192827Quadra-PMedacta International S.A.20206—
+9K220405Amis K LongMedacta International S.A.20220—
+9K210062Mectaplug PE IIMedacta International S.A.20210—