510(k) Report

Devices descending from K131377

9 later devices reach Hemicap MTP Resurfacing Hemi-Arthroplasty Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+1K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+1K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+2K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+3K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+3K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+3K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+4K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+4K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—