# K233241: SOLACE Sacroiliac Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ht Medical, LLC Dba Xenix Medical
- Decided: Oct 27, 2023 after 29 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: 22 generations back to K930834 (1993). 151 ancestors in all.
1 later device descends 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)
- K231829: Xenix Medical Sacroiliac Fixation System, Ht Medical D.B.A. Xenix Medical (2023) Summary page 5.

## Most influential descendants
- 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 SOLACE 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 SOLACE Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and nontraumatic fractures involving the sacroiliac joint. The SOLACE Sacroiliac Fixation System Navigation Instruments are intended to be used with the SOLACE 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/K233241
Methodology: https://510kreport.com/methodology