# K220441: CYGNUS™ MoRe Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Sep 16, 2022 after 212 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: 2 generations back to K974706 (1998). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190666: CYGNUS™ Anterior Cervical Plate System, MiRus, LLC (2019) Summary page 4.

## Most influential descendants
- K241175: MiRus MoRe Lumbar Plating System (2024), 0 descendants of its own

## Indications for use
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the anterior spine during the development of cervical spine fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7) Pseudoarthrosis; (8) Failed previous fusions.

Source page: https://510kreport.com/device/K220441
Methodology: https://510kreport.com/methodology