# K121312: Intramedullary Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Weigao Orthopaedic Device Co., Ltd.
- Decided: Oct 24, 2012 after 176 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 K053261 (2005). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053261: Orthofix Titanium Nailing Systems, Orthofix Srl (2005) Summary page 2.

## Most influential descendants
- K132078: Metallic Intramedullary Nail System (2014), 1 descendant of its own
- K151062: WASTON Metallic Intramedullary Nail System (2015), 0 descendants of its own
- K132428: IDEAL (2013), 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/K121312
Methodology: https://510kreport.com/methodology