# K220334: MONET Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ctl Medical Corporation
- Decided: Nov 9, 2022 after 278 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: 13 generations back to K003155 (2001). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142218: Coalition AGX Plate and Coalition AGX Spacer, Globus Medical, Inc. (2015) Summary page 4.
- K081391: Vip Anterior Cervical Plate System, Globus Medical, Inc. (2008) Summary page 4.

## Indications for use
The MONET Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft/autograft or any FDA-cleared Cervical Cage System.

Source page: https://510kreport.com/device/K220334
Methodology: https://510kreport.com/methodology