# K213901: Cyclops™ Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Degen Medical
- Decided: Jan 7, 2022 after 24 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: 10 generations back to K922087 (1992). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191786: Cyclops™ Anterior Cervical Plate System, Degen Medical, Inc. (2019) Summary page 4.
- K150759: Hyper-C Anterior Cervical Plate System, Degen Medical (2015) Summary page 4.

## Indications for use
The DeGen Medical Cyclops™ Anterior Cervical Plate System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Cyclops™ Anterior Cervical Plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2 to T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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) Spinal Stenosis Trauma (i.e. fracture or dislocation) Deformity or curvatures (including scoliosis, kyphosis, or lordosis) Spinal Tumors Pseudoarthrosis or failed previous fusion Spondylolisthesis Decompression of the spinal following total or partial cervical vertebrectomy

Source page: https://510kreport.com/device/K213901
Methodology: https://510kreport.com/methodology