510(k) Report

Devices descending from K180929

5 later devices reach Klassic HD® Hip System through their predicates, nearest generation first.

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