# K122823: Sign Pediatric Fin Nail

- Pathway: 510(k) (Traditional)
- Applicant: Sign Fracture Care International
- Decided: Apr 16, 2013 after 214 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). 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)
- K993956: Titanium Pediatric Femoral Nail, Biomet, Inc. (1999) Summary page 1.
- K043200: Sign Fin Nail, Surgical Implant Generation Network (Sign) (2005) Summary page 1.

## Indications for use
The SIGN Pediatric Fin Nail is indicated for internal fixation of diaphyseal fractures of the femur, osteotomies, correction of malunions and nonunions on patients who are anatomically suited to receive the device.

Source page: https://510kreport.com/device/K122823
Methodology: https://510kreport.com/methodology