510(k) Report

Devices descending from K014164

30 later devices reach Great Toe Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023770K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Kinetikos Medical, Inc.200229—
+2K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210—
+2K120029Hemi Phalangeal Implant Surgical Instrument SetSolana Surgical, LLC20120—
+2K092047Ascension Metal Great Toe SystemAscension Orthopedics, Inc.20101—
+2K0729223S Hemi ToeTrilliant Surgical, Ltd.200701
+2K062908Orthropro Hemi ToeOrthopro, LLC20061—
+2K060536Osteomed 1ST MPJ Hemi Implant SystemOsteomed LP200616—
+2K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.200423—
+3K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical20230—
+3K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+3K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+3K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+3K090127Metatarsal Decompression Implant, Model 100Solana Surgical, LLC20092—
+3K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815—
+3K071243Metal Hemi ImplantOrthopro, LLC200701
+3K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc.200718—
+3K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc.200716—
+3K063058Arthrex Anatoemic Phalangeal ProsthesisArthrex, Inc.20070—
+4K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+4K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+4K201393restor3d MTP ImplantRestor3D, Inc.202201
+4K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+4K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+4K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+4K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.20170—
+4K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+4K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP200813—
+5K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+5K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+5K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111—