Paragon 28, Inc. · Class II · Cleared Jul 14, 2025
| K-number | K251850 |
| Device name | Phantom® Hindfoot TTC/TC Nail System |
| Applicant | Paragon 28, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Jul 14, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Phantom® Hindfoot TTC/TC Nail System is an intramedullary fixation device comprised of nails, screws, and accessories used to stabilize the hindfoot and ankle through tibiotalocalcaneal arthrodesis (fusion). It is indicated for treating post-traumatic arthritis, degenerative joint disease, failed ankle procedures, talar deficiency, neuromuscular deformities, rheumatoid arthritis, nonunions, severe fractures, Charcot foot, and other hindfoot/ankle pathologies requiring stabilization.
The subject device possesses similar basic design, materials, manufacturing processes, and comparable dimensions to the predicate. Key modifications include longer nails and incorporation of a clothes pin–style tip design in the Phantom® Hindfoot TTC Trauma Nails variant.
Not stated in this summary.
The subject device is substantially equivalent because it shares identical indications for use, materials, design principles, and fundamental operating principles as the predicate device K191782. Engineering analysis demonstrated that the design modifications (longer nails and the clothes pin-style tip) do not raise new safety or effectiveness concerns, and the modified designs perform equivalently to the predicate devices.
View the full FDA submission: accessdata.fda.gov