# K220379: IMPEACE and IMPEACE-Uni Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Medynus, Inc.
- Decided: Mar 3, 2022 after 21 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 K973854 (1998). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173099: Fortis and Hana Anterior Cervical Plate System, Huvexel Co., Ltd. (2017) Summary page 5.

## Indications for use
The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: - degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confined by history and radiographic studies), spondylolisthesis, traumna (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e.. scoliosis., kyphosis, and/or lordosis), tumor., pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K220379
Methodology: https://510kreport.com/methodology