# K183084: Fuji Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Altus Partners, LLC
- Decided: May 29, 2019 after 204 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: 12 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)
- K163061: Altus Spine Cervical Plate System, Altus Partners, LLC (2017) Summary page 4.

## Indications for use
The Fuji Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Fuji Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

Source page: https://510kreport.com/device/K183084
Methodology: https://510kreport.com/methodology