# K240484: MSFX Mikron Cervical Anterior Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Mikron Makina Sanayi VE Ticaret Ltd. Sti.
- Decided: Apr 17, 2024 after 57 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: 3 generations back to K000536 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211718: Venus Cervical Plate System, Artfx Medical, LLC (2022) Summary page 5.
- K083562: Stryker Spine Nulock Anterior Cervical Plating System, Stryker Corp. (2009) Summary page 6.

## Indications for use
The MSFX Mikron Cervical Anterior 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/K240484
Methodology: https://510kreport.com/methodology