# K213815: SiJoin®T3

- Pathway: 510(k) (Traditional)
- Applicant: Vgi Medical, Inc.
- Decided: Mar 29, 2023 after 477 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: 16 generations back to K841189 (1984). 123 ancestors in all.
No later device cites it as a predicate yet.
0 of 124 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.

## Indications for use
The SiJoin®T3 is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Two SiJoin® T3 implants must be used in the same sacroiliac joint.

Source page: https://510kreport.com/device/K213815
Methodology: https://510kreport.com/methodology