# K190666: CYGNUS™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: May 9, 2019 after 55 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: 1 generation back to K974706 (1998). 3 ancestors in all.
2 later devices descend 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)
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 4.
- K001794: Ebi Anterior Cervical Plate System, Ebi, L.P. (2000) Summary page 4.
- K974706: Aesculap Abc Cervical Plating System, Aesculap, Inc. (1998) Summary page 4.

## Most influential descendants
- K220441: CYGNUS™ MoRe Anterior Cervical Plate System (2022), 1 descendant of its own
- K241175: MiRus MoRe Lumbar Plating System (2024), 0 descendants of its own

## Indications for use
The CYGNUS™ 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 spinal 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) Pseudarthrosis; (8) Failed previous fusions.

Source page: https://510kreport.com/device/K190666
Methodology: https://510kreport.com/methodology