# K211205: Prase-C Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Gbs Commonwealth Co., Ltd.
- Decided: Aug 12, 2021 after 112 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: 18 generations back to K003155 (2001). 280 ancestors in all.
No later device cites it as a predicate yet.
0 of 281 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202878: Prase-AP Anterior Cervical Plate System, Gbs Commonwealth Co., Ltd. (2021) Summary page 4.
- K191584: FORTICO Anterior Cervical Fixation System, Camber Spine Technologies, LLC (2019) Summary page 4.
- K182418: V3 Segmental Plating System, Atlas Spine, Inc. (2018) Summary page 4.

## Indications for use
The Prase-C 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/K211205
Methodology: https://510kreport.com/methodology