# K221021: Femoral Trochanteric Nail System – Neonail

- Pathway: 510(k) (Traditional)
- Applicant: Neoortho Produtos Ortopédicos S/A
- Decided: Dec 6, 2022 after 244 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: 9 generations back to K970097 (1997). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200869: Gamma3 System, Stryker Trauma GmbH (2020) Summary page 5.
- K141103: Intramedullary Nail and Screws-Neonail, Neoortho Produtos Ortopedicos S/A (2014) Summary page 5.

## Indications for use
The Femoral Trochanteric Nail System – Neonail is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur.

Source page: https://510kreport.com/device/K221021
Methodology: https://510kreport.com/methodology