Cleared Special

Argo Knotless GENESYS Anchor

K244025 · Conmed Corporation · Orthopedic
Jan 2025
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K244025 is an FDA 510(k) clearance for the Argo Knotless GENESYS Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on January 28, 2025, 32 days after receiving the submission on December 27, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K244025 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2024
Decision Date January 28, 2025
Days to Decision 32 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