# K222448: UNITY Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Medical Corporation
- Decided: Oct 13, 2022 after 59 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: 7 generations back to K903810 (1990). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173201: UNITY Sacroiliac Joint Fixation System, Huvexel Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System (2023), 1 descendant of its own
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own

## Indications for use
The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K222448
Methodology: https://510kreport.com/methodology