Cleared Traditional

OSSIOfiber? Suture Anchor

K254055 · OSSIO , Ltd. · Orthopedic
Feb 2026
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K254055 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 February 24, 2026, 69 days after receiving the submission on December 17, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K254055 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2025
Decision Date February 24, 2026
Days to Decision 69 days
Submission Type Traditional
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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