# K163061: Altus Spine Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Altus Partners, LLC
- Decided: Feb 6, 2017 after 97 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: 11 generations back to K922087 (1992). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091396: Cardo Medical Anterior Cervical Plate System, Cardo Medical Corp. (2009) Summary page 4.
- K073530: Accin Anterior Cervical Plate System, Accelerated Innovation, LLC (2008) Summary page 4.
- K040003: Vertebron SCP Cervical Plate System, Vertebron, Inc. (2004) Summary page 4.

## Most influential descendants
- K183084: Fuji Cervical Plate System (2019), 0 descendants of its own

## Indications for use
The Altus Spine 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 Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

Source page: https://510kreport.com/device/K163061
Methodology: https://510kreport.com/methodology