# K243835: TiLink-P SI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: SurGenTec, LLC
- Decided: Dec 27, 2024 after 14 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: 20 generations back to K841189 (1984). 133 ancestors in all.
No later device cites it as a predicate yet.
0 of 134 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242141: TiLink-P SI Joint Fusion System, SurGenTec, LLC (2024) Summary page 5.
- K230446: TiLink-L SI Joint Fusion System, SurGenTec, LLC (2023) Summary page 5.
- K231831: TiLink-L Joint Fusion System, Surgentec (2023) Summary page 5.
- K110472: SI-Fix Sacroiliac Joint Fusion System, Medtronic Sofamor Danek (2012) Summary page 5.

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

Source page: https://510kreport.com/device/K243835
Methodology: https://510kreport.com/methodology