# K170693: Phantom Small Bone Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Jun 19, 2017 after 104 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K954385 (1996). 183 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140397: Paralock Plating System / Tuffnek Screw, Paragon 28 (2014) Summary page 4.

## Most influential descendants
- K182307: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System (2019), 8 descendants of its own
- K192163: TTC Phantom® Intramedullary Nail System (2020), 6 descendants of its own
- K191782: TTC Phantom Intramedullary Nail System (2019), 6 descendants of its own
- K201227: Phantom® Hindfoot TTC/TC Nail System (2020), 5 descendants of its own
- K210869: Phantom Hindfoot TTC/TC Nail System (2021), 2 descendants of its own

## Indications for use
The Phantom™ Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

Source page: https://510kreport.com/device/K170693
Methodology: https://510kreport.com/methodology