# K121815: Nuvasive Sage Lateral Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive, Inc.
- Decided: Oct 23, 2012 after 125 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 K022791 (2002). 7 ancestors in all.
469 later devices descend from it; 2 cite it directly.
1 of 477 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061789: Lateral Plate System, Nuvasive, Inc. (2006) Summary page 1.
- K072339: Nuvasive Anterior Lumbar Plate System, Nuvasive, Inc. (2007) Summary page 1.
- K081568: Antegra-T, Synthes Spine Co.Lp (2008) Summary page 1.

## Most influential descendants
- K131723: Coroent Single Tab System (2013), 466 descendants of its own
- K140479: Coroent XL-F System (2014), 465 descendants of its own
- K160051: NuVasive® Interfixated Interbody System (2016), 396 descendants of its own
- K153782: NuVasive® Lumbar Interbody Implants (2016), 390 descendants of its own
- K161230: NuVasive Lumbar Interbody Implants (2016), 381 descendants of its own

## Indications for use
The NuVasive Sage 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-L5) 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/K121815
Methodology: https://510kreport.com/methodology