# K191584: FORTICO Anterior Cervical Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies, LLC
- Decided: Oct 22, 2019 after 130 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: 17 generations back to K003155 (2001). 273 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132324: Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System, Uniplate 2 Anterior Cervical Plate Syst, Medos International SARL (2013) Summary page 4.
- K092146: Xtend Anterior Cervical Plate System, Globus Medical, Inc. (2009) Summary page 4.
- K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System, Globus Medical, Inc. (2018) Summary page 4.
- K182885: Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2019) Summary page 4.
- K141632: Zevo (TM) Anterior Cervical Plate System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K232256: Alcantara Thoracolumbar Plate System (2024), 0 descendants of its own
- K211205: Prase-C Anterior Cervical Plate System (2021), 0 descendants of its own

## Indications for use
The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K191584
Methodology: https://510kreport.com/methodology