510(k) Report

Devices descending from K991990

105 later devices reach Tri-Polar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+6K252067Velora Acetabular SystemRestor3D, Inc.20250—