# K261112: CastleLoc-P Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: May 6, 2026 after 33 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: 21 generations back to K853033 (1985). 277 ancestors in all.
No later device cites it as a predicate yet.
1 of 278 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System, L&K BIOMED Co., Ltd. (2023) Summary page 5.
- K143271: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 5.

## Indications for use
The Castleloc-P 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/K261112
Methodology: https://510kreport.com/methodology