510(k) Report

Devices descending from K190543

5 later devices reach Cannulated Hemi Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+1K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+1K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+2K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+2K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—