# K202268: CrossRoads Tray System

- Pathway: 510(k) (Traditional)
- Applicant: Crossroads Extremity Systems, LLC
- Decided: Dec 30, 2020 after 141 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: 8 generations back to K844002 (1984). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200632: TCAT TKA Instrument Tray Set, THINK Surgical, Inc. (2020) Summary page 4.

## Most influential descendants
- K241927: Synthes Graphic Case & Tray System (2025), 1 descendant of its own
- K253791: PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (2026), 0 descendants of its own
- K241050: CrossRoads Modular Tray System (2024), 0 descendants of its own

## Indications for use
The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The CrossRoads Tray System are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst-case CrossRoads Tray System included surgical instruments such as drills, inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Tray System were validated for a maximum load of 8.5 lbs (tray + instruments). Method: Steam Sterilization (Moist Heat Sterilization) Cycle Prevacuum Temperature: 270 ˚F (132 ˚C) Exposure time: 4 minutes Drying time: 20 minutes The tray is 20.60” length x 9.80” width x 2.00” depth.

Source page: https://510kreport.com/device/K202268
Methodology: https://510kreport.com/methodology