Cleared Traditional

Aevumed FENIX Suture Anchor

K254306 · Aevumed, Inc. · Orthopedic
Mar 2026
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K254306 is an FDA 510(k) clearance for the Aevumed FENIX Suture Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Aevumed, Inc. (Malvern, US). The FDA issued a Cleared decision on March 4, 2026, 63 days after receiving the submission on December 31, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K254306 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2025
Decision Date March 04, 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