# K230591: TriLEAP Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Crossroads Extremity Systems
- Decided: Sep 29, 2023 after 210 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: 12 generations back to K954385 (1996). 113 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 5.
- K223342: MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System, Crossroads Extremity Systems, LLC (2023). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K253178: TRILEAP Plating System (2026), 0 descendants of its own

## Indications for use
The TRILEAP™ 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/K230591
Methodology: https://510kreport.com/methodology