# K150666: uNion Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Ulrich Medical USA
- Decided: Jun 22, 2015 after 98 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: 6 generations back to K971730 (1997). 28 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130030: Zavation Cervical Plate System, Zavation, LLC (2013) Summary page 4.
- K112533: Zavation Cervical Plate System, Zavation, LLC (2011) Summary page 4.
- K080646: C-Tek Maxan Anterior Cervical Plate System, Biomet Spine (2008) Summary page 4.
- K133518: Maxan Anterior Cervical Plate System, Biomet Spine (Aka Ebi, LLC) (2014) Summary page 4.
- K042544: Uniplate Anterior Cervical Plate System, Depuy Spine, Inc. (2004) Summary page 4.

## Most influential descendants
- K240515: uNion® MAX Cervical Plate System (2024), 0 descendants of its own
- K202227: Artus™ cervical plate system (2020), 0 descendants of its own
- K200927: Transept Cervical Plate System (2020), 0 descendants of its own

## Recalls of this device
- Mar 7, 2017 · Class II · Z-1878-2017: Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

## Indications for use
The uNion™ Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

Source page: https://510kreport.com/device/K150666
Methodology: https://510kreport.com/methodology