# K250908: Virata Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: SeaSpine Orthopedics Corporation
- Decided: Jun 18, 2025 after 84 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K901587 (1990). 167 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222110: Mariner RDX System, SeaSpine Orthopedics Corporation (2022) Summary page 5.
- K132014: GSB Global Spinal Balance System, Nuvasive, Inc. (2013) Summary page 5.
- K172517: SeaSpine Navigation System, SeaSpine Orthopedics Corporation (2018) Summary page 5.

## Most influential descendants
- K260786: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 1 descendant of its own
- K262828: KHEIRON® Spinal Fixation System, including patient specific K-ROD (2026), 0 descendants of its own

## Recalls of this device
- Sep 19, 2025 · Class II · Z-0478-2026: Polyaxial screws do not meet performance standards.

## Indications for use
The intended use of the Virata Spinal Fixation System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: - degenerative disc disease (ODD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, - spondylolisthesis, - trauma (i.e., fracture or dislocation), - spinal stenosis, - deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), - spinal tumor, - pseudarthrosis, and/or - failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, the Virata Spinal Fixation System is also indicated as adjunct to fusion to treat: - Adolescent Idiopathic Scoliosis (AIS) - Neuromuscular scoliosis - Congenital scoliosis The Virata Spinal Fixation System can be used with components of the Mariner and Malibu Systems such as rods and connectors. The Virata Spinal Fixation System is intended to be used with autograft or allograft. Virata Spinal Fixation Navigated Instruments The Virata Spinal Fixation Navigated Instruments are intended to be used in the preparation and placement of Virata screws during spinal 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, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Source page: https://510kreport.com/device/K250908
Methodology: https://510kreport.com/methodology