Cleared Traditional

K210869 - Phantom Hindfoot TTC/TC Nail System

K210869 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 97-day FDA review.

K210869 · Paragon 28, Inc. · Orthopedic device
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Jun 2021
Decision
97d
Days
Class 2
Risk

K210869 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 June 28, 2021 after a review of 97 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 K210869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2021
Decision Date June 28, 2021
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K210869.
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