# K190025: EVOL® -SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Cutting Edge Spine, LLC
- Decided: Aug 12, 2019 after 217 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). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171595: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, Medacta International S.A. (2017) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.

## Most influential descendants
- K213030: Curiteva Porous PEEK Cervical Interbody Fusion System (2023), 3 descendants of its own
- K214123: T-FIX® 3DSI Joint Fusion System (2022), 1 descendant of its own
- K252205: Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System (2026), 0 descendants of its own
- K254061: Curiteva Porous PEEK Cervical Interbody Fusion System (2026), 0 descendants of its own
- K240250: 3D Printed PEEK Interbody System (2024), 0 descendants of its own

## Indications for use
The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K190025
Methodology: https://510kreport.com/methodology