# K211785: CASSATT™ SIJ Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Oct 17, 2022 after 495 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: 22 generations back to K841189 (1984). 242 ancestors in all.
No later device cites it as a predicate yet.
1 of 243 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211449: Triton™ Sacroiliac Joint Fixation System, Choice Spine, LLC (2021). Cleared while this submission was under review Summary page 4.
- K162121: Siconus SI Joint Fixation System, Camber Spine Technologies (2017) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.

## Indications for use
The CASSATTTM SIJ Fixation System is intended for fixation of sacroiliac joint disruptions and intended for sacroiliac joint fusion for conditions including. * Sacroiliac joint disruptions, * Degenerative sacroiliitis, * To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and * Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Source page: https://510kreport.com/device/K211785
Methodology: https://510kreport.com/methodology