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KWD — Prosthesis, Toe, Hemi-, Phalangeal Class II

FDA Device Classification

Classification Details

Product Code
KWD
Device Class
Class II
Regulation Number
888.3730
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240268accufix surgicalAccu-Joint Hemi ImplantFebruary 29, 2024
K221220montross extremity medicalMontross Extremity Medical Hemi Implant SystemApril 19, 2023
K222964biopolyBioPoly Lesser Toe Hemiarthroplasty ImplantNovember 22, 2022
K201393restor3drestor3d MTP ImplantMay 25, 2022
K203634biopolyBioPoly Great Toe Hemiarthroplasty ImplantFebruary 2, 2021
K200951accufix surgicalAccu-Joint Hemi ImplantDecember 8, 2020
K190261arthrosurfaceBOSS Toe Fixation SystemAugust 14, 2019
K190543vilex in tennesseeCannulated Hemi ImplantMay 31, 2019
K161279life spineLife Spine Metatarsal Hemi ImplantFebruary 1, 2017
K152454arthrosurfaceHemiCAP MTP Resurfacing Hemi-Arthroplasty SystemApril 11, 2016
K131377arthrosurfaceHEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANTNovember 19, 2013
K131187solana surgicalLESSER METATARSAL HEAD IMPLANT SYSTEMOctober 22, 2013
K121973bioproBIOPRO HEMI-EDGE TOE SYSTEMOctober 30, 2012
K113752solana surgicalMETATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETFebruary 6, 2012
K120029solana surgicalHEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETFebruary 6, 2012
K102401vilexHEMI IMPLANT; MINI HEMI IMPLANTJuly 20, 2011
K092047ascension orthopedicsASCENSION METAL GREAT TOE SYSTEMJanuary 14, 2010
K090127solana surgicalMETATARSAL DECOMPRESSION IMPLANT, MODEL 100May 1, 2009
K083469metasurgMETASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000February 13, 2009
K081876osteomedOSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATINGAugust 1, 2008