# K153638: Bicortical Fixation Screw & Washer Nut System

- Pathway: 510(k) (Traditional)
- Applicant: First Ray, LLC
- Decided: Apr 19, 2016 after 123 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). 132 ancestors in all.
No later device cites it as a predicate yet.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 4.
- K152072: CrossRoads Screw System, Crossroads Extremity Systems, LLC (2015) Summary page 4.

## Indications for use
The Bicortical Fixation Screw & Washer Nut 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/K153638
Methodology: https://510kreport.com/methodology