510(k) Report

Devices descending from K042037

116 later devices reach M2A Magnum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K192126AMIStem-P Short NeckMedacta International S.A.20191—
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K181254Quadra PMedacta International S.A.20187—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+7K202730Quadra-PMedacta International S.A.20201—
+7K192827Quadra-PMedacta International S.A.20206—
+8K220405Amis K LongMedacta International S.A.20220—
+8K210062Mectaplug PE IIMedacta International S.A.20210—