Extremity Medical LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
28
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0952-2013Class IIExtremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number January 10, 2013
Z-0752-2013Class IIExtremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring devMarch 22, 2012
Z-0438-2013Class IIIO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 April 25, 2011
Z-0344-2013Class IIIO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service:April 13, 2011

Recent 510(k) Clearances

K-NumberDeviceDate
K250536MetaFore Small Screw SystemOctober 8, 2025
K251128Extremity Medical External Fixation SystemMay 7, 2025
K241563Extremity Medical External Fixation SystemFebruary 21, 2025
K212297Omni Foot and Ankle Plating SystemAugust 20, 2021
K211261Axis Charcot Fixation SystemMay 28, 2021
K201556Intraosseous Fixation SystemJuly 8, 2020
K191525KinematX Total Wrist Arthroplasty SystemMarch 4, 2020
K192592Axis Plating SystemNovember 21, 2019
K181067AlignX Ankle Fusion SystemMay 23, 2018
K180808Omni Foot Plating SystemMay 22, 2018
K172260Omni Foot Plating SystemNovember 6, 2017
K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemJuly 13, 2017
K160191Align Anterior Ankle Fusion PlateMarch 25, 2016
K152710HammerFiX DeviceOctober 15, 2015
K150309Extremity Medical Calcaneal Osteotomy DeviceMarch 4, 2015
K150166Extremity Medical Suture AnchorFebruary 23, 2015
K143402Extremity Medical Calcaneal Osteotomy DeviceFebruary 4, 2015
K133636EXTREMITY MEDICAL HAMMERTOE DEVICEMarch 28, 2014
K130120EXTREMITY MEDICAL IP FUSION SYSTEMApril 11, 2013
K121349IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHERJuly 18, 2012