# K230721: ATEC Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 9, 2023 after 55 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: 31 generations back to K841189 (1984). 1,025 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,026 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202624: Z-Span Plate System, Zavation Medical Products, LLC (2020) Summary page 4.
- K092108: Truss Thoracolumbar Plate System, Globus Medical, Inc. (2009) Summary page 4.
- K180166: Life Spine Lumbar Fixation System (SENTRY), Life Spine, Inc. (2018) Summary page 4.
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System, Alphatec Spine, Inc. (2022) Summary page 4.
- K182808: Aspida® Anterior Lumbar Plating System, Alphatec Spine, Inc. (2018) Summary page 4.

## Indications for use
The ATEC Lateral Plate System is intended 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 (LL1- 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), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K230721
Methodology: https://510kreport.com/methodology