Cleared Traditional

Ankle Truss System (ATS)

K230088 · 4Web Medical, Inc. · Orthopedic

Mar 2024

Decision

434d

Days

Class 2

Risk

About This 510(k) Submission

K230088 is an FDA 510(k) clearance for the Ankle Truss System (ATS), a Ankle Fusion Cage (Class II — Special Controls, product code SAI), submitted by 4Web Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on March 21, 2024, 434 days after receiving the submission on January 12, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K230088 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2023
Decision Date	March 21, 2024
Days to Decision	434 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	SAI — Ankle Fusion Cage
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3020
Definition	Intended For Use As An Accessory To A Tibiotalocalcaneal Intramedullary (im) Rod As Part Of A Fusion Construct For Failed Ankle Arthrodesis Or Failed Ankle Arthroplasty. Not Intended For Standalone Use.