Cleared Traditional

MetaFore Small Screw System

K250536 · Extremity Medical, LLC · Orthopedic
Oct 2025
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K250536 is an FDA 510(k) clearance for the MetaFore Small Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on October 8, 2025, 226 days after receiving the submission on February 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K250536 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2025
Decision Date October 08, 2025
Days to Decision 226 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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