# K190425: CastleLoc-P Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Mar 21, 2019 after 27 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 K994239 (2000). 6 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143271: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 4.

## Most influential descendants
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (2022), 6 descendants of its own
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (2023), 3 descendants of its own
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (2023), 2 descendants of its own
- K223521: ZESPIN SI Joint Fusion System (2023), 2 descendants of its own

## Indications for use
The 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/K190425
Methodology: https://510kreport.com/methodology