# K230446: TiLink-L SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Jun 7, 2023 after 106 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: 6 generations back to K903810 (1990). 19 ancestors in all.
3 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)
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 4.
- K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System, Spinefrontier, Inc. (2015) Summary page 4.

## Most influential descendants
- K231831: TiLink-L Joint Fusion System (2023), 2 descendants of its own
- 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/K230446
Methodology: https://510kreport.com/methodology