Cleared Special

K201227 - Phantom Hindfoot TTC/TC Nail System

K201227 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 Special 510(k) pathway after a 72-day FDA review.

K201227 · Paragon 28, Inc. · Orthopedic device
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Jul 2020
Decision
72d
Days
Class 2
Risk

K201227 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 July 17, 2020 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Paragon 28, Inc. devices

Submission Details

510(k) Number K201227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2020
Decision Date July 17, 2020
Days to Decision 72 days
Submission Type Special
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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Mcra, LLC
Samuel Pollard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

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