# K183117: PathLoc-L MIS Spinal System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Nov 15, 2018 after 6 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K950697 (1995). 65 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161766: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- K200267: LOSPA® IS™ Spinal Fixation System (2020), 1 descendant of its own
- K252139: Kentrospine Viktr-MIS® Pedicle screw system (2026), 0 descendants of its own
- K240180: Orthopeasia Spinal Fixation System (2024), 0 descendants of its own
- K200789: LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System (2020), 0 descendants of its own

## Indications for use
The PathLoc-L MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach. The PathLoc-L MIS Spinal System is intended for the following indications: * Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Trauma (i.e., fracture or dislocation) * Spinal stenosis * Curvatures (i.e., scoliosis, kyphosis, lordosis) * Tumor * Pseudarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K183117
Methodology: https://510kreport.com/methodology