510(k) Report

Devices descending from K100761

4 later devices reach Biopro Polar Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.20250—
+1K191297iNSitu Bipolar Hip SystemTheken Companies, LLC201911
+1K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+2K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—