510(k) Report

Devices descending from K173104

6 later devices reach Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+1K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+2K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+2K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+2K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+3K243809Biolox® Delta Revision headsLimacorporate20250—