# K232211: REUNION Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Astura Medical
- Decided: Oct 24, 2023 after 90 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: 15 generations back to K841189 (1984). 126 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.
- K203671: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, Medacta International S.A. (2021) Summary page 5.

## Most influential descendants
- K252346: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
The REUNION SI Joint System is indicated for skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K232211
Methodology: https://510kreport.com/methodology