510(k) Report

Devices descending from K960538

121 later devices reach Opteon Unipolar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+8K260831Z1 Hip SystemZimmer, Inc.20260—
+8K252401implaFit® short stemsImplantcast GmbH20260—
+8K251906Z1 Hip SystemZimmer, Inc.20251—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K232371Actinia® hip stemsImplantcast GmbH20231—
+8K192126AMIStem-P Short NeckMedacta International S.A.20191—
+8K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+8K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+8K181254Quadra PMedacta International S.A.20187—
+8K170473C2 femoral stemLima Corporate S.P.A.20170—
+8K160011H-Max S stemLima Corporate S.P.A.20161—
+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—