Cleared Traditional

OSSIOfiber? Interference Screw

K252022 · OSSIO , Ltd. · Orthopedic
Aug 2025
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K252022 is an FDA 510(k) clearance for the OSSIOfiber? Interference Screw, 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 August 19, 2025, 50 days after receiving the submission on June 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K252022 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2025
Decision Date August 19, 2025
Days to Decision 50 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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