# K200789: LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Dec 4, 2020 after 253 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: 14 generations back to K990745 (1999). 153 ancestors in all.
No later device cites it as a predicate yet.
0 of 154 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182544: AccelFix Spinal Fixation System, L&K BIOMED Co., Ltd. (2019) Summary page 5.
- K112643: Focus Mis System, L&K BIOMED Co., Ltd. (2012) Summary page 5.
- K120140: Focus Spinal System, L&K BIOMED Co., Ltd. (2012) Summary page 5.
- K161766: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2016) Summary page 5.
- K183117: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2018) Summary page 5.

## Indications for use
The MIS Spinal Systems are 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 MIS Spinal System can be used in an open approach and a percutaneous approach. The 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 The MIS Spinal Systems are 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 MIS Spinal System can be used in an open approach and a percutaneous approach. The 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/K200789
Methodology: https://510kreport.com/methodology