Class Class II
APEX 3D Total Ankle Replacement System (K250641)
Description
APEX 3D Total Ankle Replacement System by Paragon 28, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250641
Clearance Date2025-05-01
Clearance TypeTraditional
Product CodeHSN
Regulation Number888.3110
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250641
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. APEX 3D Total Ankle Replacement System (K250641) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | 2020 |
| K120906 | ZIMMER TRABECULAR METAL TOTAL ANKLE | Zimmer, Inc. | 2012 |
Trace the full predicate network for K250641
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.