# K240212: COGNiTiON™ Staple System

- Pathway: 510(k) (Special)
- Applicant: Ortho Solutions UK, Ltd.
- Decided: Feb 23, 2024 after 29 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K000684 (2000). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 5.

## Indications for use
The Ortho Solutions COGNiTiON ™ Staple System is indicated for hand and foot bone fragments, osteotomy, fixation and joint arthrodesis. The COGNiTiON ™ Staple System is not intended for spinal use.

Source page: https://510kreport.com/device/K240212
Methodology: https://510kreport.com/methodology