# K251940: PathLoc Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Mar 3, 2026 after 252 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). 279 ancestors in all.
No later device cites it as a predicate yet.
1 of 280 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192481: AccelFix Lumbar Plate System, L&K BIOMED Co., Ltd. (2020) Summary page 5.
- K173885: Genesys Spine Binary Lumbar Plate System, Genesys Spine (2018) Summary page 5.
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System, L&K BIOMED Co., Ltd. (2023) Summary page 5.
- K192678: Genesys Spine Binary® Lumbar Plate System, Genesys Spine (2019) Summary page 5.

## Indications for use
The PathLoc Lumbar Plate System is indicated for use via the anterior 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 conformed 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/K251940
Methodology: https://510kreport.com/methodology