Cleared Traditional

PediFlex? Flexible Nail System

K251362 · OrthoPediatrics Corp. · Orthopedic
Jun 2025
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K251362 is an FDA 510(k) clearance for the PediFlex? Flexible Nail System, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on June 24, 2025, 54 days after receiving the submission on May 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251362 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2025
Decision Date June 24, 2025
Days to Decision 54 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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