Class Class II
Phantom® Hindfoot TTC/TC Nail System (K251850)
Description
Phantom® Hindfoot TTC/TC Nail System by Paragon 28, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251850
Clearance Date2025-07-14
Clearance TypeSpecial
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251850
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Phantom® Hindfoot TTC/TC Nail System (K251850) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2020 |
| K191782 | TTC Phantom Intramedullary Nail System | Paragon 28, Inc. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253591 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | 2026 |
Trace the full predicate network for K251850
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.