# K231829: Xenix Medical Sacroiliac Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ht Medical D.B.A. Xenix Medical
- Decided: Aug 15, 2023 after 55 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: 21 generations back to K930834 (1993). 150 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222605: iFuse TORQ® Implant System, SI-BONE, Inc. (2022) Summary page 5.
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.
- K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System, Spinefrontier, Inc. (2015) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.

## Most influential descendants
- K233241: SOLACE Sacroiliac Fixation System (2023), 1 descendant of its own
- K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology (2026), 0 descendants of its own

## Indications for use
The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for: • Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions • Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K231829
Methodology: https://510kreport.com/methodology