Cleared Special

Arthrex FiberTak Suture Anchor

K250596 · Arthrex, Inc. · Orthopedic
Mar 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K250596 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 March 28, 2025, 28 days after receiving the submission on February 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250596 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2025
Decision Date March 28, 2025
Days to Decision 28 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