510(k) Report

Devices descending from K020580

17 later devices reach X-Series BI-Metric Hip Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+1K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+1K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.20061—
+1K023409HA X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc.200201
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+2K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+2K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+2K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp20080—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—