510(k) Report

Devices descending from K070052

18 later devices reach Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+1K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+1K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+1K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+1K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210—
+1K090127Metatarsal Decompression Implant, Model 100Solana Surgical, LLC20092—
+1K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815—
+2K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+2K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+2K201393restor3d MTP ImplantRestor3D, Inc.202201
+2K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.20170—
+2K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+2K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+2K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP200813—
+3K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+3K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+3K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+3K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111—