TTC Phantom Intramedullary Nail System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K192163 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TTC Phantom Intramedullary Nail System is an orthopedic device, comprising intramedullary nails, screws, and accessory components. It is used for tibiotalocalcaneal (TTC) or tibiocalcaneal (TC) arthrodesis. The system offers various diameter and length options to address different patient anatomies. The nails have a consistent distal diameter of Ø13.3 mm through the joint spaces, adding strength to the implant.
The TTC Phantom Intramedullary Nail System is supplied in different lengths, including 150 mm, 175 mm, 200 mm, 250 mm, and 300 mm, and diameters of Ø10 mm, Ø11.5 mm, and Ø13 mm. The system has received FDA 510K authorization. It is designed to accommodate variations in patient anatomy, with the proximal end of the nails and screws inserting through the bone to provide stability.
Frequently asked questions
What is the TTC Phantom Nail System used for?
The TTC Phantom Nail System is used for tibiotalocalcaneal (TTC) or tibiocalcaneal (TC) arthrodesis, providing stability to the implant through its consistent distal diameter and various length options.
What sizes are available for the TTC Phantom Nail System?
The system is supplied in different lengths, including 150 mm, 175 mm, 200 mm, 250 mm, and 300 mm, and diameters of Ø10 mm, Ø11.5 mm, and Ø13 mm, to accommodate variations in patient anatomy.
Is the TTC Phantom Nail System supplied sterile?
The description does not specify if the TTC Phantom Nail System is supplied sterile, but it is designed for orthopedic use and should be handled accordingly.
Is the TTC Phantom Nail System a single-use or reusable device?
The device description does not explicitly state if the TTC Phantom Nail System is for single-use or reusable, but its design as an implant suggests it is typically used once per patient.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Phantom® Hindfoot TTC/TC System - Paragon 28, PDF Phantom Hindfoot TTC Trauma Nail System - paragon28.com, TTC Phantom Intramedullary Nail System (K191782) - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192163 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
- FDA Applicant
- Paragon 28, Inc.
Sources (1)
- FDA 510(k) K192163 24 fields · synced Sep 22, 2026