# K243838: NEXXT MATRIXX® SI System

- Pathway: 510(k) (Traditional)
- Applicant: Nexxt Spine
- Decided: Mar 14, 2025 after 91 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: 23 generations back to K930834 (1993). 219 ancestors in all.
No later device cites it as a predicate yet.
0 of 220 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241574: iFuse TORQ® Implant System, SI-BONE, Inc. (2024) Summary page 5.
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.

## Indications for use
The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for: * Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis. * Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.

Source page: https://510kreport.com/device/K243838
Methodology: https://510kreport.com/methodology