# K130825: Azure Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Orthofix, Inc.
- Decided: May 7, 2013 after 42 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K922087 (1992). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121658: Orthofix Acp (Anterior Cervical Plate System), Orthofix, Inc. (2012) Summary page 1.
- K050892: Hallmarktm Anterior Cervical Plate System, Blackstone Medical, Inc. (2005) Summary page 1.
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates, Blackstone Medical, Inc. (2010) Summary page 1.

## Most influential descendants
- K143028: Azure Anterior Cervical Plate System (2015), 0 descendants of its own

## Recalls of this device
- Oct 29, 2013 · Class II · Z-1089-2014: There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.

## 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/K130825
Methodology: https://510kreport.com/methodology