# K111866: Nuvasive Anterior Lumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Jul 22, 2011 after 22 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: 3 generations back to K922543 (1993). 7 ancestors in all.
35 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072339: Nuvasive Anterior Lumbar Plate System, Nuvasive, Inc. (2007) Summary page 1.
- K052546: Aegis Anterior Lumbar Plate System, Depuy Spine, Inc. (2006) Summary page 1.

## Most influential descendants
- K130868: Nuvasive Decade Lateral Plate System (2013), 19 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own
- K192006: SIRION Lateral Lumbar Interbody System (2020), 14 descendants of its own
- K203065: Lumbar Spine Truss System Plating Solution (LSTS-PS) (2021), 9 descendants of its own
- K202495: SIRION Lateral Lumbar Interbody Fusion (2021), 6 descendants of its own

## Indications for use
The NuVasive Halo 11Anterior Lumbar 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 (TI1-5) 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/K111866
Methodology: https://510kreport.com/methodology