510(k) Report

Devices descending from K031859

23 later devices reach Cap Great Toe Resurfacing Hemi-Arthroplasty Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+1K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+1K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+1K092047Ascension Metal Great Toe SystemAscension Orthopedics, Inc.20101—
+1K090127Metatarsal Decompression Implant, Model 100Solana Surgical, LLC20092—
+1K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815—
+1K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc.200718—
+1K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc.200716—
+1K063058Arthrex Anatoemic Phalangeal ProsthesisArthrex, Inc.20070—
+2K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+2K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical20230—
+2K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+2K201393restor3d MTP ImplantRestor3D, Inc.202201
+2K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+2K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+2K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+2K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.20170—
+2K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+2K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210—
+2K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP200813—
+3K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+3K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+3K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111—