510(k) Report

Devices descending from K050937

14 later devices reach Trabecular Metal Acetabular Revision Shells through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+1K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+2K182109REDAPT Modular Acetabular ShellSmith & Nephew, Inc.20184—
+2K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+2K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc.20175—
+2K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.20164—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+3K190847REDAPT Blade AugmentsSmith & Nephew, Inc.20190—