# K202878: Prase-AP Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Jan 29, 2021 after 123 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: 5 generations back to K994239 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190425: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2019) Summary page 4.

## Most influential descendants
- K211205: Prase-C Anterior Cervical Plate System (2021), 0 descendants of its own

## Indications for use
The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • spondylolisthesis • trauma (i.e. fractures or dislocations) • tumors • deformity (defined as kyphosis, lordosis, or scoliosis) • pseudoarthrosis • failed previous fusion • spinal stenosis

Source page: https://510kreport.com/device/K202878
Methodology: https://510kreport.com/methodology