510(k) Report

Devices descending from K121034

11 later devices reach Ioi Total Hip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+1K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+1K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+1K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+1K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+2K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+2K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+3K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011