# K222493: CODA™ Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Nov 18, 2022 after 92 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: 4 generations back to K953730 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103491: Skyline Anterior Cervical Plate System, A Johnson & Johnson Company (2011). Our reading of the summary gave K103494, FDA’s number for Zenostar Magic Glaze (Wieland Dental + Technik GmbH & Co. KG). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SKYLINE ANTERIOR CERVICAL PLATE SYSTEM”.

## Most influential descendants
- K230993: CODA™ Anterior Cervical Plate System (2023), 0 descendants of its own

## Indications for use
The CODA Anterior Cervical Plate System is intended for anterior fixation of the cervical spine (C2-C7) as an adjunct to fusion is skeletally mature patients. Specific indications include: 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.

Source page: https://510kreport.com/device/K222493
Methodology: https://510kreport.com/methodology