# K220809: Drive Rail System

- Pathway: 510(k) (Special)
- Applicant: OrthoPediatrics Corp.
- Decided: Apr 8, 2022 after 18 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: 1 generation back to K140822 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140822: Drive Rail System, Devise Ortho, Inc. (2014) Summary page 4.

## Indications for use
The Drive Rail System is intended to be used on adult or pediatric patients in the treatment of conditions of the long bones of the arms and legs including limb lengthening, acute or gradual multiplanar correction of long bone deformities, fractures and diseases which generally may result in joint contractures or loss of range of motion, fractures requiring distraction, open or closed fractures, non- unions, and infected fractures or non-unions.

Source page: https://510kreport.com/device/K220809
Methodology: https://510kreport.com/methodology