510(k) Report

Devices descending from K203634

2 later devices reach BioPoly Great Toe Hemiarthroplasty Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+1K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—