# K240935: ARENAL Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Effortmed, LLC
- Decided: May 17, 2024 after 42 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: 8 generations back to K922087 (1992). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162638: CETRA Anterior Cervical Plate System, Orthofix, Inc. (2016) Summary page 4.
- K211718: Venus Cervical Plate System, Artfx Medical, LLC (2022) Summary page 4.

## Indications for use
The ARENAL Anterior Cervical Plate System is intended for fixation and temporary stabilization of the anterior cervical spine (C2-T1) during the development of cervical spine fusions in patients with the 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) - Trauma (including fractures) - Tumors - Deformities or curvatures (including kyphosis, lordosis, or scoliosis) - Pseudarthrosis - Spondylolisthesis - Spinal stenosis

Source page: https://510kreport.com/device/K240935
Methodology: https://510kreport.com/methodology