# K213456: Xenco Medical Multilevel CerviKit

- Pathway: 510(k) (Traditional)
- Applicant: Xenco Medical, LLC
- Decided: Dec 21, 2021 after 56 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 K953730 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160702: ZION Anterior Cervical Fixation System, Astura Medical (2016) Summary page 4.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 4.

## Indications for use
The Xenco Medical Multilevel CerviKit is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). 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) spondylolisthesis, 3) trauma (including fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions and/or 8) spinal stenosis.

Source page: https://510kreport.com/device/K213456
Methodology: https://510kreport.com/methodology