510(k) Report

Devices descending from K004043

131 later devices reach Metal Transcend Articulation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+6K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+6K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+6K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+6K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+6K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+7K260831Z1 Hip SystemZimmer, Inc.20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K251906Z1 Hip SystemZimmer, Inc.20251—
+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—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+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—
+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—