# K260989: Varion Thoracolumbar Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Kyocera Medical Technologies Inc. (KMTI)
- Decided: May 15, 2026 after 51 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: 31 generations back to K841189 (1984). 1,130 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210539: CoreLink Midline Fixation System, Corelink, LLC (2021) Summary page 6.
- K201648: Sterispine™ PS, Safe Orthopaedics (2020) Summary page 6.
- K223494: CD Horizon Spinal System, Medtronic (2023) Summary page 6.

## Indications for use
The KMTI Varion Thoracolumbar Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used for posterior non-cervical screw fixation in pediatric patients, the Varion Thoracolumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the Varion Thoracolumbar Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach and is intended to be used with autograft and/or allograft. The KMTI Varion Navigated Instruments System is intended to be used during the preparation and placement of KMTI screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The KMTI Varion Navigated Instruments System is specifically designed for use with the Medtronic® StealthStation TM 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 for the anatomy.

Source page: https://510kreport.com/device/K260989
Methodology: https://510kreport.com/methodology