# K061808: Darco Locking Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Darco International, Inc.
- Decided: Aug 17, 2006 after 51 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K022325 (2002). 1 ancestor in all.
410 later devices descend from it; 24 cite it directly.
0 of 412 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022325: Normed Titanium Osteotomy Plating System, Osteomedics, Inc. (2002) Summary page 1.

## Most influential descendants
- K073624: Modular Foot System (2008), 342 descendants of its own
- K100618: Maxlock Extreme Extremity Plating System with Variable Angle Technology (2010), 339 descendants of its own
- K081513: Merete 3.0 and 3.5 MM Locking Screws (2008), 256 descendants of its own
- K090063: Merete Locking Bone Plate System (2009), 241 descendants of its own
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System (2010), 228 descendants of its own

## Recalls of this device
- Feb 9, 2022 · Class II · Z-0679-2022: Product was labelled with the incorrect manufacturing and distribution dates.
- Dec 3, 2021 · Class II · Z-0393-2022: The incorrect product is contained in the packaging.
- Nov 8, 2016 · Class II · Z-0573-2020: The firm discovered a lack of adequate documentation confirming sterility on certain products.

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

Source page: https://510kreport.com/device/K061808
Methodology: https://510kreport.com/methodology