# K131984: Synthes Synsonic Ulna Nail

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Mar 31, 2014 after 276 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 K042135 (2004). 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)
- K042135: Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension), Synthes (Usa) (2004) Summary page 1.
- K073402: Synthes Olecranon Osteotomy Nailing System, Synthes (Usa) (2008) Summary page 1.
- K090175: Unity Beta Plla System, Bonutti Research, Inc. (2009) Summary page 1.

## Indications for use
The Synthes Synsonic Ulna Nail System is intended to treat shaft fractures of the ulna, impending pathological fractures, malunions, and nonunions.

Source page: https://510kreport.com/device/K131984
Methodology: https://510kreport.com/methodology