510(k) Report

Devices descending from K112158

13 later devices reach Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243809Biolox® Delta Revision headsLimacorporate20250—
+1K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+1K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+1K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+1K141327Minima S SystemLima Corporate S.P.A.20145—
+1K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K231925MINIMA S SystemLima Corporate S.P.A.20230—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K170473C2 femoral stemLima Corporate S.P.A.20170—
+2K160011H-Max S stemLima Corporate S.P.A.20161—
+2K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K261576Icona Hip StemCorin, Ltd.20260—