510(k) Report

Devices descending from K152454

6 later devices reach HemiCAP MTP Resurfacing Hemi-Arthroplasty System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+2K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+2K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+2K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+3K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+3K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—