# K210402: Curiteva Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Curiteva, Inc.
- Decided: Sep 9, 2021 after 211 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). 127 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 130 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151462: SI-Technology® SI-Desis® Screws, Si-Technology, LLC (2015) Summary page 4.
- K191748: Genesys Spine Sacroiliac Joint Fusion System, Genesys Spine (2019) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.

## Most influential descendants
- K243565: DYNAMIS™ SI Screw System (2025), 1 descendant of its own
- K251075: DYNAMIS™ Implant System (2025), 0 descendants of its own

## Indications for use
The Curiteva Sacroiliac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K210402
Methodology: https://510kreport.com/methodology