Class Class II
Phantom Fibula Nail System (K234128)
Description
Phantom Fibula Nail System by Paragon 28, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234128
Clearance Date2024-08-22
Clearance TypeTraditional
Product CodeHSB
Regulation Number888.3020
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234128
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 Fibula Nail System (K234128) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173656 | Arthrex FibuLock Nail | Arthrex, Inc. | 2018 |
| K163014 | AOS Small Bone Nailing System | Advanced Orthopaedic Solutions, Inc... | 2017 |
| K143276 | Acumed Small Bone IM Nail System | Acumed, LLC | 2015 |
Trace the full predicate network for K234128
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.