Cleared Traditional

Arthrex Nano FiberTak Suture Anchor

K254229 · Arthrex, Inc. · Orthopedic
Mar 2026
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K254229 is an FDA 510(k) clearance for the Arthrex Nano 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 2, 2026, 63 days after receiving the submission on December 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K254229 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2025
Decision Date March 02, 2026
Days to Decision 63 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