Cleared Special

FiberTape Button

K260405 · Arthrex, Inc. · Orthopedic
Mar 2026
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K260405 is an FDA 510(k) clearance for the FiberTape Button, 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 9, 2026, 28 days after receiving the submission on February 9, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K260405 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2026
Decision Date March 09, 2026
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