510(k) Report

Devices descending from K002106

117 later devices reach New Bio-Moore Endo Head, Taper Adapter through their predicates, nearest generation first.

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