# K231831: TiLink-L Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: Surgentec
- Decided: Aug 3, 2023 after 42 days
- Product code: OUR (Sacroiliac Joint Fixation)
- 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: 7 generations back to K903810 (1990). 20 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230446: TiLink-L SI Joint Fusion System, SurGenTec, LLC (2023) Summary page 4.

## Most influential descendants
- K261381: TiLink-L™ SI Joint Fusion System (2026), 0 descendants of its own
- K243835: TiLink-P SI Joint Fusion System (2024), 0 descendants of its own

## Indications for use
The TiLink-L Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K231831
Methodology: https://510kreport.com/methodology