# K081230: Trauson Intramedullary Nail

- Pathway: 510(k) (Traditional)
- Applicant: Trauson (Jiangsu) Medical Instrument Co., Ltd.
- Decided: Jan 13, 2009 after 258 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: 2 generations back to K982953 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072161: Biomet Femoral Locking Nail System, Biomet Manufacturing Corp (2007) Summary page 2.
- K050241: Aos Humeral Nail, Advanced Orthopaedic Solutions, Inc. (2005) Summary page 2.

## Indications for use
Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease.

Source page: https://510kreport.com/device/K081230
Methodology: https://510kreport.com/methodology