Cleared Traditional

Arthrex FiberTak Suture Anchor

K251809 · Arthrex, Inc. · Orthopedic
Jul 2025
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K251809 is an FDA 510(k) clearance for the Arthrex FiberTak 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 July 18, 2025, 36 days after receiving the submission on June 12, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251809 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2025
Decision Date July 18, 2025
Days to Decision 36 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