# K211718: Venus Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Artfx Medical, LLC
- Decided: Jun 28, 2022 after 389 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stryker Spine Surgical Anterior Cervical Plating System: named in the summary without a submission number

## Most influential descendants
- K240935: ARENAL Anterior Cervical Plate System (2024), 0 descendants of its own
- K240484: MSFX Mikron Cervical Anterior Plate System (2024), 0 descendants of its own

## Indications for use
The Venus Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine 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 -Failed previous fusion -Decompression of the spinal cord following total or partial cervical vertebrectomy -Spondylolisthesis -Spinal stenosis.

Source page: https://510kreport.com/device/K211718
Methodology: https://510kreport.com/methodology