# K042317: Cervical Plate

- Pathway: 510(k) (Special)
- Applicant: Scient'X
- Decided: Sep 24, 2004 after 29 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 K971730 (1997). 3 ancestors in all.
63 later devices descend from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013439: Anterior Cervical Plate System, Scien'Tx USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K070681: Next Generation Anterior Cervical Plating System (2007), 62 descendants of its own
- K102820: Appliance, Fixation, Spinal Intervertebral Body (2010), 38 descendants of its own
- K112533: Zavation Cervical Plate System (2011), 26 descendants of its own
- K163104: Terrace™ Anterior Cervical Plate System (2017), 18 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own

## Indications for use
The Cervical Plate is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during development of a solid fusion in patients with 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, • pseudoarthrosis, and * failed previous fusion. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K042317
Methodology: https://510kreport.com/methodology