# K253178: TRILEAP Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Crossroads Extremity Systems
- Decided: Jan 6, 2026 after 102 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K954385 (1996). 114 ancestors in all.
No later device cites it as a predicate yet.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230591: TriLEAP Plating System, Crossroads Extremity Systems (2023) Summary page 5.

## Indications for use
The TRI LEAP Plating System is indicated for fixation of bones and bone fragments of the foot and ankle in adults and adolescents (aged 12 -21 years) where the growth plates have fused.

Source page: https://510kreport.com/device/K253178
Methodology: https://510kreport.com/methodology