Cleared Traditional

Biosteon? Screw

K251680 · Biocomposites, Ltd. · Orthopedic
Feb 2026
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K251680 is an FDA 510(k) clearance for the Biosteon? Screw, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on February 17, 2026, 263 days after receiving the submission on May 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K251680 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date February 17, 2026
Days to Decision 263 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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