Cleared Traditional

Arthrex SutureTak Suture Anchor

K252314 · Arthrex, Inc. · Orthopedic
Oct 2025
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K252314 is an FDA 510(k) clearance for the Arthrex SutureTak Suture Anchor, 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 October 29, 2025, 96 days after receiving the submission on July 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K252314 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2025
Decision Date October 29, 2025
Days to Decision 96 days
Submission Type Traditional
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