Phantom Intramedullary Nail System
FDA 510(k)Class II (US FDA 510(k))
by Paragon 28
Identifiers
- 510(k) Number
- K191782 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 Intramedullary Nail System is a surgical implant designed for tibiotalocalcaneal (TTC) or tibiocalcaneal (TC) arthrodesis, providing internal fixation of the hindfoot. It consists of intramedullary nails with varying diameters (Ø10 mm, Ø11.5 mm, Ø13 mm) and lengths (150 mm, 175 mm, 200 mm, 250 mm, 300 mm) to stabilize bone segments during fusion procedures. The nails feature a distal diameter of Ø13.3 mm for enhanced joint-space strength, ensuring robust fixation where it is most critical.
The system is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under FDA 510(k) clearance (K191782) as substantially equivalent to existing devices, with review by the Orthopedic (OR) Advisory Committee. Nails are available in specified diameters and lengths to accommodate different anatomical requirements, and proper storage conditions must be maintained to preserve sterility and integrity.
Frequently asked questions
What types of surgical procedures is the TTC Phantom Intramedullary Nail System specifically designed for?
The TTC Phantom Intramedullary Nail System is designed for tibiotalocalcaneal (TTC) and tibiocalcaneal (TC) arthrodesis procedures. It provides internal fixation to stabilize the hindfoot bones during fusion surgery, ensuring proper alignment and support during the healing process.
How are the nails in this system sized, and why does the distal diameter differ from the rest?
The nails come in diameters of 10 mm, 11.5 mm, and 13 mm, with lengths ranging from 150 mm to 300 mm to accommodate varying anatomical needs. The distal end of each nail has a fixed diameter of 13.3 mm to reinforce joint-space fixation, providing stronger support where it is most critical for stability during fusion.
Is the TTC Phantom Intramedullary Nail System intended for reuse, or is it meant to be used only once?
The system is explicitly intended for single-use in orthopedic surgical settings. This ensures sterility and safety for each patient, as reuse could compromise integrity and introduce infection risks.
How should the TTC Phantom Intramedullary Nail System be stored to maintain its sterility and functionality?
The system is supplied sterile, so storage conditions must preserve this sterility and the nails’ structural integrity. Proper storage—typically in a sealed, sterile packaging—should follow manufacturer guidelines to prevent contamination or damage before use.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The TTC Phantom Intramedullary Nail System received FDA clearance via a 510(k) submission (K191782) under a Special review classification, determined to be substantially equivalent to existing devices. This means it was evaluated by the Orthopedic Advisory Committee to ensure it meets safety and effectiveness standards for its intended surgical use in TTC/TC arthrodesis.
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® Intramedullary Nail - Paragon 28, Phantom® Hindfoot TTC/TC System - Paragon 28, PDF Phantom® Small Bone Intramedullary Nail System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191782 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragon 28
- FDA Applicant
- Paragon 28, Inc.
Sources (1)
- FDA 510(k) K191782 24 fields · synced Sep 19, 2026