# K250712: Linkt Compression Staple System

- Pathway: 510(k) (Traditional)
- Applicant: Trax Surgical
- Decided: May 14, 2025 after 65 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: 6 generations back to K902307 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203832: FuseForce™ Flex Dynamic Compression System, Wright Medical (2021) Summary page 5.
- K210482: Medline UNITE REFLEX Nitinol Staple System, Medline Industries, Inc. (2021) Summary page 5.
- K231885: Medline UNITE® REFLEX® Nitinol Staple System, Medline Industries, LP (2023) Summary page 5.

## Indications for use
The Linkt ™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Source page: https://510kreport.com/device/K250712
Methodology: https://510kreport.com/methodology