Cleared Special

Arthrex TightRope Soft Button, RT

K250424 · Arthrex, Inc. · Orthopedic
Mar 2025
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K250424 is an FDA 510(k) clearance for the Arthrex TightRope Soft Button, RT, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 11, 2025, 25 days after receiving the submission on February 14, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250424 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2025
Decision Date March 11, 2025
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040