# K131609: Double Engine Intrameddullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Double Engine Medical Material Co., Ltd.
- Decided: May 21, 2014 after 352 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- 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 K040762 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040762: Synthes (Usa) Tibial Nail System EX, Synthes (Usa) (2004) Summary page 2.

## Most influential descendants
- K253046: HERA Interlocking Intramedullary Nailing System (2026), 0 descendants of its own

## Indications for use
Double Engine Intramedullary Nail System is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.

Source page: https://510kreport.com/device/K131609
Methodology: https://510kreport.com/methodology