# K232311: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Aug 14, 2023 after 12 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: 20 generations back to K040583 (2004). 327 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 329 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231636: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System., L&K BIOMED Co., Ltd. (2023) Summary page 5.
- K120270: Venus Spinal Fixation System, L&K BIOMED Co., Ltd. (2012) Summary page 5.
- K143363: VENUS Spinal Fixation System, L&K BIOMED Co., Ltd. (2015) Summary page 5.
- K171813: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System, L&K BIOMED Co., Ltd. (2017) Summary page 5.
- K183168: OpenLoc-L Spinal Fixation System, L&K BIOMED Co., Ltd. (2018) Summary page 5.
- K200790: LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System, L&K BIOMED Co., Ltd. (2020) Summary page 5.
- K223565: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System., L&K BIOMED Co., Ltd. (2022) Summary page 5.
- K230245: LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System, L&K BIOMED Co., Ltd. (2023) Summary page 5.
- K182544: AccelFix Spinal Fixation System, L&K BIOMED Co., Ltd. (2019) Summary page 5.
- K200794: AccelFix Spinal Fixation System, L&K BIOMED Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- K261130: AccelFix Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. This device is indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis). The AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K232311
Methodology: https://510kreport.com/methodology