# K252776: ARIES Anterior Cervical Plate Systems

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: May 14, 2026 after 254 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: 9 generations back to K953730 (1995). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021461: Atlantis Vision Anterior Cervical Plate System, Medtronic Sofamor Danek (2002) Summary page 5.
- K130640: Atlantis Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 6.
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011) Summary page 6.
- K231090: Zevo Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2023) Summary page 6.

## Indications for use
The ARIES Anterior Cervical Plate Systems is intended for anterior interbody screw fixation from C2-T1 in the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) Trauma (including fractures) 3) Tumors 4) Deformity (defined as kyphosis, lordosis, or scoliosis) 5) Pseudarthrosis, and/or 6) Failed previous fusions

Source page: https://510kreport.com/device/K252776
Methodology: https://510kreport.com/methodology