# K130019: J-Screw Compression Screw

- Pathway: 510(k) (Traditional)
- Applicant: Competitive Engineering, Inc.
- Decided: Nov 18, 2014 after 684 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: 5 generations back to K960385 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990804: Stayfuse, Pioneer Surgical Technology (1999) Summary page 4.
- K110445: Flexfusion (TM) Fixation Implant, Nextremity Solutions, LLC (2011) Summary page 4.
- K122031: Nextra TI Hammertoe Correction System, Nextremity Solutions, LLC (2012) Summary page 4.
- K052736: Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT, Arthrex, Inc. (2005) Summary page 4.

## Indications for use
The J-Screw indicated for use in osteotomy, reconstruction, arthrodesis, joint fusion, fracture repair, and fracture fixation of small bones of the upper and lower extremities.

Source page: https://510kreport.com/device/K130019
Methodology: https://510kreport.com/methodology