Cleared Traditional

K192163 - TTC Phantom® Intramedullary Nail System

K192163 is an FDA 510(k) clearance for TTC Phantom Intramedullary Nail System, manufactured by Paragon 28, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K192163 · Paragon 28, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K192163

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.

HSB Device Classification - Class 2, Special Controls

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 460
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