# K183060: CervAlign™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Decided: Jan 17, 2019 after 76 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). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130427: Pioneer Aspect Anterior Cervical Plate System, Pioneer Surgical Technology, Inc. (2013) Summary page 4.
- K083663: PACP, Pioneer Surgical Technology (2009) Summary page 4.

## Most influential descendants
- K211408: CervAlign® Anterior Cervical Plate System (2021), 1 descendant of its own
- K251436: Resolve Anterior Cervical Plate System (2025), 0 descendants of its own

## Recalls of this device
- Jan 15, 2021 · Class II · Z-1218-2021: Locking mechanism has been observed to disassociate either intraoperatively or postoperatively resulting in replacement/revision

## Indications for use
The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K183060
Methodology: https://510kreport.com/methodology