# K230857: TiLink-P SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Sep 25, 2023 after 180 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: 17 generations back to K841189 (1984). 127 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 4.
- K221047: SILO TFX MIS Sacroiliac Joint Fixation System, Aurora Spine, Inc. (2022) Summary page 4.

## Most influential descendants
- K240720: TiLink-P SI Joint Fusion System (2024), 3 descendants of its own
- K242141: TiLink-P SI Joint Fusion System (2024), 1 descendant of its own
- K243835: TiLink-P SI Joint Fusion System (2024), 0 descendants of its own
- K242414: TiLink-P Joint Fusion System (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K230857
Methodology: https://510kreport.com/methodology