Paragon 28, Inc. · Class II · Cleared Mar 5, 2026
| K-number | K253591 |
| Device name | Phantom® Hindfoot TTC/TC Nail System |
| Applicant | Paragon 28, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Mar 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Phantom® Hindfoot TTC/TC Nail System is an intramedullary nail fixation device used for tibiotalocalcaneal arthrodesis (ankle and hindfoot fusion) and stabilization. It includes intramedullary nails, screws, and accessories in various sizes to treat conditions such as post-traumatic arthritis, failed ankle surgery, avascular necrosis, Charcot foot, and severe ankle deformity.
The device is identical to the predicate device in design, materials, processing, and performance. The only modification is the addition of MRI safety and compatibility testing and updated MRI safety labeling to designate the device as 'MR Conditional.'
ASTM F2119 (MR Image Artifact Evaluation), ASTM F2052 (Magnetically Induced Displacement Force), ASTM F2213 (Magnetically Induced Torque), ASTM F2182 (RF Induced Heating), and ASTM F2503 (Marking Medical Devices for Safety in the MR Environment).
View the full FDA submission: accessdata.fda.gov