# K181600: PathLoc-SI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jul 16, 2018 after 28 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: 8 generations back to K903810 (1990). 19 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have 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.

## Most influential descendants
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System (2021), 10 descendants of its own
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System (2022), 6 descendants of its own
- K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (2023), 3 descendants of its own
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (2023), 2 descendants of its own
- K223521: ZESPIN SI Joint Fusion System (2023), 2 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/K181600
Methodology: https://510kreport.com/methodology