Cleared Special

OSSIOfiber? Suture Anchor

K251309 · OSSIO , Ltd. · Orthopedic
May 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251309 is an FDA 510(k) clearance for the OSSIOfiber? Suture Anchor, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by OSSIO , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on May 27, 2025, 29 days after receiving the submission on April 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251309 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2025
Decision Date May 27, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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