# K132078: Metallic Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Walkman Biomaterial Co., Ltd.
- Decided: Mar 19, 2014 after 257 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 K053261 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121312: Intramedullary Nail System, Weigao Orthopaedic Device Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K151062: WASTON Metallic Intramedullary Nail System (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K132078
Methodology: https://510kreport.com/methodology