# K192494: NexGen Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine
- Decided: Oct 29, 2019 after 48 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: 6 generations back to K953730 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160702: ZION Anterior Cervical Fixation System, Astura Medical (2016) Summary page 4.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 4.
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 4.
- K082273: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2008) Summary page 4.
- K100070: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2010) Summary page 4.

## Indications for use
The NexGen Anterior Cervical Plate System is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (DDD) (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (including fractures or dislocations); spinal tumors; deformity (defined as kyphosis, lordosis, or scoliosis); spinal stenosis; pseudoarthrosis; and failed previous fusions.

Source page: https://510kreport.com/device/K192494
Methodology: https://510kreport.com/methodology