# K230689: T-FIX™ 3DSI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: Cutting Edge Spine, LLC
- Decided: Apr 5, 2023 after 23 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: 19 generations back to K930834 (1993). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214123: T-FIX® 3DSI Joint Fusion System, Cutting Edge Spine, LLC (2022) Summary page 5.

## Indications for use
The T-FIX™ 3DSI Joint Fusion 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 of thoracolumbar fusion and acute, non-acute and non-traumatic fractures involving the sacroiliac joint

Source page: https://510kreport.com/device/K230689
Methodology: https://510kreport.com/methodology