# K240201: PathLoc SI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Feb 23, 2024 after 29 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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). 152 ancestors in all.
No later device cites it as a predicate yet.
1 of 153 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231841: PathLoc SI Joint Fusion System, L&K BIOMED Co., Ltd. (2023) Summary page 4.

## Indications for use
The Pathloc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K240201
Methodology: https://510kreport.com/methodology