# K252106: External Fixation Mini Rail System

- Pathway: 510(k) (Traditional)
- Applicant: Paragon 28, Inc.
- Decided: Sep 30, 2025 after 89 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple 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: 10 generations back to K962823 (1996). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202143: Dynex Micro, Vilex, LLC (2020) Summary page 6.
- K162032: Arrowhead Mini-Rail Fixator, Arrowhead De, LLC (2017) Summary page 6.

## Indications for use
The External Fixation Mini Rail System is intended for external fixation and is indicated for stabilization of fractures and osteotomy, foot arthrodesis, adult and pediatric leg lengthening, and correction of bone deformity in the lower extremities. The External Fixation Mini Rail System is intended to be used in pediatric patients that are children aged 2 years to less than 12 years and adolescents aged 12 through 21 years (up to but not including the 22nd birthday).

Source page: https://510kreport.com/device/K252106
Methodology: https://510kreport.com/methodology