Cleared Special

Syndesmosis TightRope PRO

K253727 · Arthrex, Inc. · Orthopedic
Dec 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K253727 is an FDA 510(k) clearance for the Syndesmosis TightRope PRO, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on December 22, 2025, 28 days after receiving the submission on November 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K253727 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2025
Decision Date December 22, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030