Cleared Special

Aevumed PROTEKT Suture Anchor

K260004 · Aevumed, Inc. · Orthopedic
Jan 2026
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K260004 is an FDA 510(k) clearance for the Aevumed PROTEKT 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 January 28, 2026, 26 days after receiving the submission on January 2, 2026. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K260004 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2026
Decision Date January 28, 2026
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