# K191342: CrossRoads Screw System

- Pathway: 510(k) (Special)
- Applicant: Crossroads Extemity Systems, LLC
- Decided: Aug 19, 2019 after 91 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K962616 (1996). 92 ancestors in all.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143039: CrossRoads Screw System, Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem (2015) Summary page 4.
- K152072: CrossRoads Screw System, Crossroads Extremity Systems, LLC (2015) Summary page 4.

## Indications for use
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.

Source page: https://510kreport.com/device/K191342
Methodology: https://510kreport.com/methodology