# K251154: RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Ht Medical D.B.A. Xenix Medical
- Decided: Jun 12, 2025 after 59 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: 20 generations back to K040583 (2004). 375 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 377 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243916: Primus Spinal Fixation System, Spinal Elements, Inc. (2025) Summary page 6.
- K112759: Apclo Pedicle Screw Systems, Atlas Spine, Inc. (2011) Summary page 6.
- K212692: Mariner Pedicle Screw System, SeaSpine Orthopedics Corporation (2021) Summary page 6.
- K140454: Navigated CD Horizon Solera Screwdriver/Taps, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 6.

## 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 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 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.

Source page: https://510kreport.com/device/K251154
Methodology: https://510kreport.com/methodology