# K053581: Nuvasive Smartplate Gradient Plus System

- Pathway: 510(k) (Special)
- Applicant: Nuvasive, Inc.
- Decided: Feb 17, 2006 after 56 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
No predicates in its family tree.
105 later devices descend from it; 5 cite it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SmartPlate Gradient CLP System: named in the summary without a submission number

## Most influential descendants
- K122910: Archon Anterior Cervical Plate Syste, (2012), 101 descendants of its own
- K131025: Archon Anterior Cervical Plate System (2013), 97 descendants of its own
- K161442: NuVasive® CoRoent® Small Interlock™ System (2016), 94 descendants of its own
- K173115: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS (2017), 83 descendants of its own
- K180909: REVEL Spacers (2018), 37 descendants of its own

## Indications for use
The NuVasive SmartPlate Gradient Plus System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion. WARNING: The NuVasive SmartPlate Gradient Plus System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K053581
Methodology: https://510kreport.com/methodology