510(k) Report

Devices descending from K063370

16 later devices reach Cap 7.0MM MTP Resurfacing Hemi-Arthroplasty through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815—
+2K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+2K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210—
+2K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP200813—
+3K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.20170—
+3K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+3K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111—
+4K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+4K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+4K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+4K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+4K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+5K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+5K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+5K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+6K233592BioPoly Radial Head ImplantBioPoly, LLC20240—