Cleared Special

Y-Knotless? Flex Anchors

K253763 · Conmed Corporation · Orthopedic
Jan 2026
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K253763 is an FDA 510(k) clearance for the Y-Knotless? Flex Anchors, 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 29, 2026, 65 days after receiving the submission on November 25, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K253763 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2025
Decision Date January 29, 2026
Days to Decision 65 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