510(k) Report

Devices descending from K911378

29 later devices reach Townley Great Toe Joint through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121973Biopro Hemi-Edge Toe SystemBiopro, Inc.20122—
+1K0729223S Hemi ToeTrilliant Surgical, Ltd.200701
+1K062908Orthropro Hemi ToeOrthopro, LLC20061—
+1K031859Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.200423—
+1K021063Great Toe ImplantSignal Medical Corp.20020—
+2K200951Accu-Joint Hemi ImplantAccufix Surgical, Inc.20201—
+2K190543Cannulated Hemi ImplantVilex IN Tennessee, Inc.20195—
+2K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty SystemArthrosurface, Inc.20166—
+2K131377Hemicap MTP Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc.20139—
+2K092047Ascension Metal Great Toe SystemAscension Orthopedics, Inc.20101—
+2K090127Metatarsal Decompression Implant, Model 100Solana Surgical, LLC20092—
+2K073065Osteomed Metatarsal Resurfacing Implant SystemOsteomed LP200815—
+2K071243Metal Hemi ImplantOrthopro, LLC200701
+2K070052Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc.200718—
+2K063370Cap 7.0MM MTP Resurfacing Hemi-ArthroplastyArthrosurface, Inc.200716—
+2K063058Arthrex Anatoemic Phalangeal ProsthesisArthrex, Inc.20070—
+3K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.20260—
+3K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.20240—
+3K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity Medical20230—
+3K222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLC20221—
+3K201393restor3d MTP ImplantRestor3D, Inc.202201
+3K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC20212—
+3K190261BOSS Toe Fixation SystemArthrosurface, Inc.20190—
+3K161279Life Spine Metatarsal Hemi ImplantLife Spine, Inc.20170—
+3K131187Lesser Metatarsal Head Implant SystemSolana Surgical, LLC20130—
+3K113752Metatarsal Decompression Implant Surgical Instrument SetSolana Surgical, LLC201210—
+3K081876Osteomed Resurfacing Metatarsal Implant with Hydroxylapatite CoatingOsteomed LP200813—
+4K233592BioPoly Radial Head ImplantBioPoly, LLC20240—
+4K102401Hemi Implant; Mini Hemi ImplantVilex, Inc.201111—