# K221084: Dyna Locking Trochanteric Nail™

- Pathway: 510(k) (Special)
- Applicant: Innosys
- Decided: Mar 3, 2023 after 324 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 K970097 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093707: Dyna Locking Trochanteric Nail, Model NG0820, U&I Corp. (2010) Summary page 4.

## Indications for use
The Dyna Locking Trochanteric Nail™ is intended to be implanted into the intramedullary canal and head of femur for alignment, stabilization, fixation of fractures caused by trauma or disease including followings: - Pertrochanteric fractures - Intertrochanteric fractures - Comminuted fractures - Segmental fractures - Fracture with bone loss - Proximal and distal fractures - Non-unions and malunions - Subtrochanteric fractures(only for long nail: more than 320mm)

Source page: https://510kreport.com/device/K221084
Methodology: https://510kreport.com/methodology