510(k) Report

Devices descending from K082705

7 later devices reach Biopro Bipolar Head, Models 18130-18152 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191297iNSitu Bipolar Hip SystemTheken Companies, LLC201911
+1K171156OMNI Anseris Hip StemOmnilife Science20170—
+1K132539Ring-Lok Modular Bipolar SystemImplants International, Ltd.20140—
+1K100761Biopro Polar HeadBiopro, Inc.201041
+2K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+2K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.20250—
+2K143113Klassic BiPolar SystemTotal Joint Orthopedics201501