510(k) Report

Devices descending from K945793

11 later devices reach P.F.C.(R) Bipolar Hip System - 22MM Bipolar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100761Biopro Polar HeadBiopro, Inc.201041
+1K100151Apex Hip System Bipolar Head, Model H3-822XX (OD 38 to 43MM), H3-828XX (OD44 to 60MM)Omnlife Science20104—
+1K980801J-FX Bipolar HeadJohnson & Johnson Professionals, Inc.19980—
+2K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.20250—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K191297iNSitu Bipolar Hip SystemTheken Companies, LLC201911
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+3K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K261576Icona Hip StemCorin, Ltd.20260—