# K200956: NuVasive Thoracolumbar Plates

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: May 21, 2020 after 42 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K990745 (1999). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180166: Life Spine Lumbar Fixation System (SENTRY), Life Spine, Inc. (2018) Summary page 6.
- K130868: Nuvasive Decade Lateral Plate System, Nuvasive, Inc. (2013) Summary page 6.
- K121837: Nuvasive Brigade Anterior Plate System, Nuvasive, Inc. (2012) Summary page 6.
- K103750: Nuvasive Traverse Plate System, Nuvasive, Inc. (2011) Summary page 6.

## Indications for use
The NuVasive Decade Lateral Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery. The NuVasive Brigade Anterior Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L.1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery. The NuVasive Traverse Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, spondylolysis, spondylolisthesis, and pseudarthrosis or a failed previous spine surgery.

Source page: https://510kreport.com/device/K200956
Methodology: https://510kreport.com/methodology