# K172699: Agile Nail

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix Srl
- Decided: Apr 23, 2018 after 228 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 K982953 (1998). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070843: Synthes Adolescent Lateral Entry Femoral Nail System, Synthes (Usa) (2007) Summary page 4.
- K083726: Pedinail Intramedullary Nailing System, OrthoPediatrics Corp. (2009) Summary page 4.

## Indications for use
The Agile Nail is intended for insertion in the medullary canal of a femur for the alignment and the stabilization of fractures, and for the correction of deformities. It is indicated for the treatment of subtrochanteric fractures and of femoral shaft fractures, in pediatric patients, with the exception of newborns and infants, and in adult patients with an appropriate medullary canal. The indications include: prophylactic nailing of impending pathologic fractures; fixation of femurs that have been surgically prepared (osteotomy); nonunions and malunions; reconstruction following tumor resection and grafting and bone lengthening and shortening.

Source page: https://510kreport.com/device/K172699
Methodology: https://510kreport.com/methodology