510(k) Report

Devices descending from K021349

125 later devices reach Metal Transcend Articulation System (Larger Sizes) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+6K232371Actinia® hip stemsImplantcast GmbH20231—
+6K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+6K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+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—