# K260015: ANTERIS Thoracolumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: SpineCraft
- Decided: Mar 4, 2026 after 58 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: 10 generations back to K990745 (1999). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183214: Raven Lumbar Plate System, Choicespine, LP (2019) Summary page 5.
- K132589: Anterior Lumbar Plate System (Presidio), Life Spine, Inc. (2013) Summary page 5.

## Indications for use
The ANTERIS Thoracolumbar Plate System Plates are intended for use via a 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 in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Trauma (i.e. fractures, including dislocation and subluxation), tumors, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, deformities (i.e. scoliosis, kyphosis, or lordosis), spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Source page: https://510kreport.com/device/K260015
Methodology: https://510kreport.com/methodology