Cleared Special

Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm

K253895 · Arthrex, Inc. · Orthopedic
Dec 2025
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K253895 is an FDA 510(k) clearance for the Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm, 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 December 30, 2025, 26 days after receiving the submission on December 4, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K253895 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2025
Decision Date December 30, 2025
Days to Decision 26 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