# K253517: Reselute Tibial Nail

- Pathway: 510(k) (Traditional)
- Applicant: Reselute, Inc.
- Decided: Mar 10, 2026 after 118 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: 5 generations back to K951740 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143245: GPC Intramedullary Nailing Systems, Gpc Medical Limited (2015) Summary page 5.
- K230761: TRIGEN META-NAIL Nail System, Smith & Nephew, Inc. (2023) Summary page 5.

## Indications for use
The Reselute Traditional Tibial Intramedullary Nail is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre and post isthmic fractures and tibial malunions and non-unions.

Source page: https://510kreport.com/device/K253517
Methodology: https://510kreport.com/methodology