# K091396: Cardo Medical Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Cardo Medical Corp.
- Decided: Aug 5, 2009 after 87 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: 10 generations back to K922087 (1992). 33 ancestors in all.
2 later devices descend 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)
- K040003: Vertebron SCP Cervical Plate System, Vertebron, Inc. (2004) Summary page 1.
- K043181: Modification to Vertebron SCP Cervical Plate System, Vertebron, Inc. (2004) Summary page 1.
- K062110: Vertebron SCP Cervical Plate System, Vertebron, Inc. (2006) Summary page 1.
- K081567: Vertebron SSP Cervical Plating System, Vertebron, Inc. (2008) Summary page 1.
- K073530: Accin Anterior Cervical Plate System, Accelerated Innovation, LLC (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K001815: DC Zirkon, Austenal, Inc. (2000). Our reading of the summary gave K001815, FDA’s number for DC Zirkon (Austenal, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Vertebron Cervical Plate Systems”. Kept off the family tree.

## Most influential descendants
- K163061: Altus Spine Cervical Plate System (2017), 1 descendant of its own
- K183084: Fuji Cervical Plate System (2019), 0 descendants of its own

## Indications for use
The Cardo Medical Cervical Plate System components are intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with: Degenerative disk disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Trauma (including fractures) Tumor Deformity (defined as kyphosis, lordosis or scoliosis) Pseudoarthrosis Failed previous fusions. The Cardo Medical Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7.

Source page: https://510kreport.com/device/K091396
Methodology: https://510kreport.com/methodology