# K231658: VEOS Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spineway
- Decided: Oct 10, 2023 after 125 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: 18 generations back to K040583 (2004). 296 ancestors in all.
No later device cites it as a predicate yet.
0 of 297 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161387: Mont Blanc and Mont Blanc MIS Spinal Systems, Spineway SA (2016) Summary page 4.
- K180179: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw, Orthofix, Inc. (2018) Summary page 4.
- K954696: Rogozinski Thoracolumbar Spinal Rod, Smith & Nephew Richards, Inc. (1996) Summary page 4.
- K121728: Tiger Spine System, Corelink, LLC (2012) Summary page 4.

## Indications for use
The VEOS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine (from T1 to S1). The VEOS Spinal Fixation System is intended for noncervical pedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VEOS Spinal Fixation System is intended for noncervical pedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, The VEOS Spinal Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach. This system is intended to be used with autograft and/or allograft.

Source page: https://510kreport.com/device/K231658
Methodology: https://510kreport.com/methodology