# K130868: Nuvasive Decade Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Aug 29, 2013 after 153 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: 4 generations back to K922543 (1993). 15 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121815: Nuvasive Sage Lateral Plate System, Nuvasive, Inc. (2012) Summary page 1.
- K111866: Nuvasive Anterior Lumbar Plate System, Nuvasive, Inc. (2011) Summary page 1.

## Most influential descendants
- K192006: SIRION Lateral Lumbar Interbody System (2020), 14 descendants of its own
- K202495: SIRION Lateral Lumbar Interbody Fusion (2021), 6 descendants of its own
- K222554: EL CAPITAN Anterior Lumbar Interbody Fusion (2023), 5 descendants of its own
- K231743: F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System (2023), 3 descendants of its own
- K240126: ProAM ALIF System (2024), 2 descendants of its own

## Indications for use
The NuVasive Decade Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (Li-Si) 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, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K130868
Methodology: https://510kreport.com/methodology