# K120140: Focus Spinal System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Feb 15, 2012 after 28 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: 8 generations back to K950697 (1995). 63 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100706: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2010) Summary page 1.
- K112643: Focus Mis System, L&K BIOMED Co., Ltd. (2012)

## Cited in the summary but kept off the family tree
- K103085: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K161766: PathLoc-L MIS Spinal System (2016), 18 descendants of its own
- 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

## Indications for use
The FOCUS 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. And the FOCUS Spinal System can be used in an open approach and a percutaneous approach with MIS instrumentation. The FOCUS Spinal System is intended for noncervical pedicle fixation 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, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous approach with MIS Instrumentation, the FOCUS Spinal System is intended for noncervical pedicle fixation 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, and for lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K120140
Methodology: https://510kreport.com/methodology