# K151062: WASTON Metallic Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Waston Medical Appliance Co., Ltd.
- Decided: Dec 17, 2015 after 241 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: 3 generations back to K053261 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132078: Metallic Intramedullary Nail System, Tianjin Walkman Biomaterial Co., Ltd. (2014) Summary page 5.

## Indications for use
*Simple, compound first- and second-degree tibial shaft fractures *Pseudarthrosis and delayed union

Source page: https://510kreport.com/device/K151062
Methodology: https://510kreport.com/methodology