510(k) Report

Devices descending from K921224

21 later devices reach Bimetric Total Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050251Balance Hip SystemBiomet, Inc.20052—
+1K020580X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc.200217—
+2K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+2K132697Encompass 10/12 Hip StemOrtho Development Corp.20140—
+2K062775European Style Taper,Press-Fit Hip StemOrtho Development Corp.2007134
+2K052089XR-Series BI-Metric Femoral ComponentsBiomet Manufacturing, Inc.20061—
+2K023409HA X-Series BI-Metric Hip Femoral ComponentsBiomet, Inc.200201
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+3K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development20144—
+3K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+3K131022Ovation 10/12 Hip StemOrtho Development Corp.20135—
+3K073637Parallel-Sided Extensively Coated Femoral StemsBiomet Manufacturing Corp20080—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—