# K161766: PathLoc-L MIS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Aug 22, 2016 after 56 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: 9 generations back to K950697 (1995). 64 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120140: Focus Spinal System, L&K BIOMED Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K182544: AccelFix Spinal Fixation System (2019), 10 descendants of its own
- K200794: AccelFix Spinal Fixation System (2020), 8 descendants of its own
- K223565: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (2022), 4 descendants of its own
- K183117: PathLoc-L MIS Spinal System (2018), 4 descendants of its own
- K230245: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System (2023), 3 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/K161766
Methodology: https://510kreport.com/methodology