Cleared Traditional

K253591 - Phantom Hindfoot TTC/TC Nail System

K253591 is the FDA 510(k) clearance for Phantom Hindfoot TTC/TC Nail System by Paragon 28, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K253591 · Paragon 28, Inc. · Orthopedic device
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Mar 2026
Decision
108d
Days
Class 2
Risk

K253591 is an FDA 510(k) clearance for the Phantom® Hindfoot TTC/TC Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on March 5, 2026 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K253591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date March 05, 2026
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 318
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K253591.
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T2 Alpha Femur Retrograde Nailing System
K253640 · Stryker GmbH · Feb 2026
Affixus® Natural Nail® Proximal Humeral System
K253749 · Zimmer Switzerland Manufacturing GmbH · Dec 2025