510(k) Report

Devices descending from K992153

15 later devices reach PE-Plus Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K141327Minima S SystemLima Corporate S.P.A.20145—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+3K231925MINIMA S SystemLima Corporate S.P.A.20230—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K261576Icona Hip StemCorin, Ltd.20260—