# K112643: Focus Mis System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jan 4, 2012 after 114 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: 7 generations back to K950697 (1995). 62 ancestors in all.
26 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.
- K103085: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 1.
- K061813: Mantis Spinal System, Stryker Spine (2006) Summary page 1.
- K041801: Expedium Mis Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.

## Most influential descendants
- K120140: Focus Spinal System (2012), 25 descendants of its own
- 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

## 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 and nonpedicle 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 Systems are intended for noncervical pedicle fixation and nonpedicle 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K112643
Methodology: https://510kreport.com/methodology