# K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jul 19, 2023 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: 20 generations back to K853033 (1985). 276 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 279 devices in its family (counting itself) has 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 5.
- K113509: Lexus Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2012) Summary page 5.
- K143279: LnK Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 5.
- K190425: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2019) Summary page 5.
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System, Aegis Spine (2021) Summary page 5.
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System, Aegis Spine, Inc. (2023) Summary page 5.
- K192481: AccelFix Lumbar Plate System, L&K BIOMED Co., Ltd. (2020) Summary page 5.
- K200794: AccelFix Spinal Fixation System, L&K BIOMED Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K261112: CastleLoc-P Anterior Cervical Plate System (2026), 0 descendants of its own
- K251940: PathLoc Lumbar Plate System (2026), 0 descendants of its own

## 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. The AccelFix Lumbar Plate System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K231839
Methodology: https://510kreport.com/methodology