510(k) Report

Devices descending from K983128

6 later devices reach Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-Xxyyy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051516Trabecular Metal Revision Shell LinersZimmer, Inc.20055—
+2K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+2K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet20250—
+2K072121Trabecular Metal Acetabular Revision System Cemented Contrained LinerZimmer, Inc.20083—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—