Cleared Traditional

K201838 - PediFlex Flexible Nail System

K201838 is an FDA 510(k) clearance for PediFlex Flexible Nail System, manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K201838 · OrthoPediatrics Corp. · Orthopedic device
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Jan 2021
Decision
211d
Days
Class 2
Risk

K201838 is an FDA 510(k) clearance for the PediFlex Flexible Nail System. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on January 29, 2021 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all OrthoPediatrics Corp. devices

FDA 510(k) Submission Details - K201838

510(k) Number K201838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2020
Decision Date January 29, 2021
Days to Decision 211 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 158
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K201838.
Small Bone Nailing System
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VeriFixx™ Small Bone Implant
K202777 · Armis Biopharma, Inc. · Nov 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K201803 · OSSIO , Ltd. · Oct 2020