510(k) Report

Devices descending from K102401

11 later devices reach Hemi Implant; Mini Hemi Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+1K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+1K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+1K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+2K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+2K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+2K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+2K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+2K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+2K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+3K233592BioPoly Radial Head ImplantBioPoly, LLC20240—