# K012881: C3 Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Vision, Inc.
- Decided: Nov 26, 2001 after 90 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: 2 generations back to K926453 (1993). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000742: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K970048: Synthes (Usa)Titanium Locking Plate System (Tilps), Synthes (Usa) (1997) Summary page 1.

## Most influential descendants
- K112809: Blue Mountain Cervical Plate (2012), 2 descendants of its own
- K150036: Blue Mountain Cervical Plate System (2015), 1 descendant of its own
- K163602: Kepler I Cervical Plate System (2017), 0 descendants of its own
- K073500: Active Anterior Cervical Plate System (2008), 0 descendants of its own

## Indications for use
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion. The C*™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis. The C®™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.

Source page: https://510kreport.com/device/K012881
Methodology: https://510kreport.com/methodology