# K180772: Met One Czar Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies
- Decided: Dec 17, 2018 after 269 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 K000536 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142237: Aviator Anterior Cervical Plate (ACP) System, Stryker Corporation (2015) Summary page 4.

## Indications for use
The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: Degenerative Disc Disease, Trauma, Spinal Stenosis, Cervical myelopathy, Deformities or Curvatures, Tumor, Pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K180772
Methodology: https://510kreport.com/methodology