# K143028: Azure Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofix, Inc.
- Decided: May 29, 2015 after 220 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). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130825: Azure Anterior Cervical Plate System, Orthofix, Inc. (2013) Summary page 4.

## Indications for use
The Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor; g) Pseudoarthrosis; h) Revision of previous surgery

Source page: https://510kreport.com/device/K143028
Methodology: https://510kreport.com/methodology