510(k) Report

Devices descending from K952088

110 later devices reach Zirconia Articul/Eze Femoral Balls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+8K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+8K181254Quadra PMedacta International S.A.20187—
+9K251052Trivicta® Hip StemOrtho Development Corp.20250—
+9K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+9K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+9K202730Quadra-PMedacta International S.A.20201—
+9K192827Quadra-PMedacta International S.A.20206—
+10K220405Amis K LongMedacta International S.A.20220—
+10K210062Mectaplug PE IIMedacta International S.A.20210—