# K241050: CrossRoads Modular Tray System

- Pathway: 510(k) (Traditional)
- Applicant: Crossroads Extremity Systems
- Decided: Jul 16, 2024 after 90 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K844002 (1984). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202268: CrossRoads Tray System, Crossroads Extremity Systems, LLC (2020) Summary page 5.

## Indications for use
The CrossRoads Modular Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during sterilization and during implant/prosthetic treatment. The CrossRoads Modular Tray System is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validations for the worst-case CrossRoads Modular Tray System included surgical instruments such as inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Modular Tray System is validated for a maximum load of 18.7 lbs (tray + instruments). Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Drying time: 20 minutes Dimensions do not exceed: 20.546" length x 10.022" width x 3.978" depth

Source page: https://510kreport.com/device/K241050
Methodology: https://510kreport.com/methodology