# K221053: Magnes-C Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Fellowship of Orthopaedic Researchers, Inc.
- Decided: Mar 1, 2023 after 324 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: 6 generations back to K971730 (1997). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130030: Zavation Cervical Plate System, Zavation, LLC (2013) Summary page 4.
- K945700: Synthes (Usa) Anterior Cervical Vertebrae Plate System, Synthes (Usa) (1995) Summary page 4.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.

## Indications for use
The Magnes-C™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

Source page: https://510kreport.com/device/K221053
Methodology: https://510kreport.com/methodology