# K231841: PathLoc SI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jul 14, 2023 after 22 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: 19 generations back to K853033 (1985). 151 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 153 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153656: PathLoc-SI Joint Fusion System, L&K BIOMED Co., Ltd. (2016) Summary page 4.
- K181600: PathLoc-SI Joint Fusion System, L&K BIOMED Co., Ltd. (2018) Summary page 4.
- 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 4.
- K223521: ZESPIN SI Joint Fusion System, Aegis Spine, Inc. (2023) Summary page 4.

## Most influential descendants
- K240201: PathLoc SI Joint Fusion System (2024), 0 descendants of its own

## 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/K231841
Methodology: https://510kreport.com/methodology