Medartis, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
44
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1549-2026Class IIBrand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16January 9, 2026
Z-1550-2026Class IIBrand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16January 9, 2026
Z-1821-2024Class IIAPTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation April 12, 2024
Z-0150-2015Class IIAPTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fraOctober 1, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMarch 7, 2025
K240613APTUS Elbow Dorsal Olecranon PlatesJune 20, 2024
K232105APTUS Foot System 2.8-3.5April 19, 2024
K234062APTUS Hand Scaphoid PlatesMarch 21, 2024
K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionNovember 3, 2023
K232324StealthFix Intraosseous Fixation SystemAugust 30, 2023
K232144Sterile Products of the APTUS SystemAugust 18, 2023
K230971APTUS® 3.5 TriLock Straight PlatesJune 2, 2023
K223853Medartis APTUS® Ulna PlatesMarch 30, 2023
K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemNovember 6, 2020
K193639APTUS® Foot 2.8-3.5 SystemMarch 26, 2020
K193633APTUS® Ankle Trauma System 2.8/3.5March 26, 2020
K193554APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 SystemFebruary 16, 2020
K192984APTUS Clavicle SystemJanuary 24, 2020
K192297APTUS Wrist Arthrodesis PlatesNovember 8, 2019
K191848APTUS Wrist Spanning Plates 2.5September 30, 2019
K191636APTUS Foot SystemAugust 16, 2019
K181009APTUS CMC-I Fusion Plate SystemAugust 24, 2018
K181425APTUS® Proximal Humerus SystemAugust 5, 2018
K172170APTUS(R) Wrist 2.5 SystemSeptember 8, 2017