# K214123: T-FIX® 3DSI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Cutting Edge Spine, LLC
- Decided: Jun 24, 2022 after 176 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: 18 generations back to K930834 (1993). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203138: FIREBIRD SI Fusion System, Orthofix, Inc. (2020) Summary page 5.
- K190025: EVOL® -SI Joint Fusion System, Cutting Edge Spine, LLC (2019) Summary page 5.
- K181881: Outlet Sacroiliac Joint Fusion System, Sij Surgical (2018) Summary page 5.

## Most influential descendants
- K230689: T-FIX™ 3DSI Joint Fusion System (2023), 0 descendants of its own

## 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/K214123
Methodology: https://510kreport.com/methodology