Cleared Traditional

K192163 - TTC Phantom Intramedullary Nail System

K192163 is the FDA 510(k) clearance for TTC Phantom Intramedullary 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 175-day FDA review.

K192163 · Paragon 28, Inc. · Orthopedic device
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Jan 2020
Decision
175d
Days
Class 2
Risk

K192163 is an FDA 510(k) clearance for the TTC Phantom® Intramedullary 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 January 31, 2020 after a review of 175 days - an extended review cycle.

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 K192163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2019
Decision Date January 31, 2020
Days to Decision 175 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
53d slower than avg
Panel avg: 122d · This submission: 175d
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 326
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K192163.
Precice® Screws
K193617 · Nuvasive Specialized Orthopedics, Inc. · May 2020
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · Zimmer GmbH · Apr 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · Stryker Trauma GmbH · Feb 2020
EBA One Nailing System
K183666 · Citieffe S.R.L. · Nov 2019
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · Zimmer GmbH · Oct 2019
Pediatric Nailing PlatformFemur
K190321 · OrthoPediatrics Corp. · Oct 2019