Cleared Special

Phantom? Hindfoot TTC/TC Nail System

K251850 · Paragon 28, Inc. · Orthopedic
Jul 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251850 is an FDA 510(k) clearance for the Phantom? Hindfoot TTC/TC Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on July 14, 2025, 28 days after receiving the submission on June 16, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number K251850 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2025
Decision Date July 14, 2025
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSB — Rod, Fixation, Intramedullary And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3020

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