510(k) Report

Devices descending from K151307

6 later devices reach ICONACY (TM) I-Hip (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+1K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+2K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+2K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+2K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011