# K013439: Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Scien'Tx USA, Inc.
- Decided: Jan 14, 2002 after 89 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: 1 generation back to K971730 (1997). 2 ancestors in all.
64 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)
- K973854: Orion Anterior Cervical Plate System, Sofamor Danek USA,Inc. (1998) Summary page 1.
- K971730: Depuy Motech Peak Polyaxial Anterior Cervical Plate System, Depuy, Inc. (1997) Summary page 1.

## Most influential descendants
- K042317: Cervical Plate (2004), 63 descendants of its own
- 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

## Indications for use
The Anterior Cervical Plate System 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 the development of a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions. WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K013439
Methodology: https://510kreport.com/methodology