Phantom Hindfoot TTC/TC Nail System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K253591 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 Phantom Hindfoot TTC/TC Nail System is an orthopedic device comprised of intramedullary nails, screws, and accessory components designed for tibiotalocalcaneal (TTC) or tibiocalcaneal (TC) arthrodesis. It includes the Phantom TTC Nail and the Phantom ActivCore Nail, offered in multiple lengths to accommodate variations in patient anatomy.
The system is supplied in three diameter options (Ø10 mm, Ø11.5 mm, and Ø13 mm) and five length options (150 mm, 175 mm, 200 mm, 250 mm, 300 mm), with all distal diameters measuring Ø13.3 mm through the joint spaces. It received FDA 510(k) clearance (K253591) as substantially equivalent and is intended for use in orthopedic procedures under traditional review pathways.
Frequently asked questions
What is the Phantom Hindfoot TTC/TC Nail System used for?
The Phantom Hindfoot TTC/TC Nail System is used for tibiotalocalcaneal (TTC) or tibiocalcaneal (TC) arthrodesis procedures, providing intramedullary stabilization of the hindfoot joint through implanted nails, screws, and accessory components.
What sizes and models are available in the Phantom Hindfoot TTC/TC Nail System?
The system includes the Phantom TTC Nail and Phantom ActivCore Nail, available in three diameter options (Ø10 mm, Ø11.5 mm, Ø13 mm) and five length options (150 mm, 175 mm, 200 mm, 250 mm, 300 mm), with all distal diameters measuring Ø13.3 mm through the joint spaces.
How is the Phantom Hindfoot TTC/TC Nail System supplied and is it sterile or single-use?
The system is supplied as a set of intramedullary nails, screws, and accessory components intended for single-use implantation in orthopedic procedures; sterility and specific packaging details are not provided in the device data.
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/TC Nail System - Paragon 28, PDF Paragon 28, Inc Edward Wells-Spicer Regulatory Affairs Specialist II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253591 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
- FDA Applicant
- Paragon 28, Inc.
Sources (1)
- FDA 510(k) K253591 24 fields · synced Sep 21, 2026