# K234128: Phantom Fibula Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Aug 22, 2024 after 238 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K960642 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163014: AOS Small Bone Nailing System, Advanced Orthopaedic Solutions, Inc. (Aos) (2017) Summary page 4.
- K173656: Arthrex FibuLock Nail, Arthrex, Inc. (2018) Summary page 4.

## Recalls of this device
- Oct 13, 2025 · Class II · Z-0871-2026: Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the as

## Indications for use
The Phantom Fibula Nail System is intended for use in the fixation of fibular fractures and osteotomies.

Source page: https://510kreport.com/device/K234128
Methodology: https://510kreport.com/methodology