# K171852: DARCO Locking Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Sep 21, 2017 after 92 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: 2 generations back to K022325 (2002). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061808: Darco Locking Bone Plate System, Darco International, Inc. (2006) Summary page 4.

## Most influential descendants
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K242348: Locking Screw,CoCrMo (2024), 0 descendants of its own

## Indications for use
The DARCO™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles, and toes. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K171852
Methodology: https://510kreport.com/methodology