# K262193: RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface Technology

- Pathway: 510(k) (Traditional)
- Applicant: Xenix Medical
- Decided: Sep 14, 2026 after 77 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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). 464 ancestors in all.
No later device cites it as a predicate yet.
0 of 465 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments, Ht Medical D.B.A. Xenix Medical (2025) Summary page 9.
- K220195: iFuse Bedrock Granite™ Implant System, SI-BONE, Inc. (2022) Summary page 9.
- K233241: SOLACE Sacroiliac Fixation System, Ht Medical, LLC Dba Xenix Medical (2023) Summary page 9.

## Indications for use
The Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: • Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) • Spondylolisthesis • Trauma (i.e. fracture or dislocation) • Spinal Stenosis • Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudoarthrosis • Failed previous fusion Xenix Medical RIVA Posterior Fixation System fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior 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® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. The RIVA Anchor Sacroiliac Fixation System is intended for sacroiliac joint fusion for: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. When connected to the Xenix Medical RIVA Posterior Fixation System, the RIVA Anchor Sacroiliac Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: • Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) • Spondylolisthesis • Trauma (i.e. fracture or dislocation) • Spinal Stenosis • Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) • Tumor • Pseudoarthrosis • Failed previous fusion Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye. Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Anchor 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® S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the 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/K262193
Methodology: https://510kreport.com/methodology