# K200794: AccelFix Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Oct 20, 2020 after 208 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). 152 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 161 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 4.

## Most influential descendants
- K223565: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (2022), 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
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (2023), 2 descendants of its own
- K231636: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. (2023), 2 descendants of its own
- K232311: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System (2023), 1 descendant of its own

## Indications for use
The AccelFix Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (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 intended as an adjunct to fusion for all of the following indications: 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/K200794
Methodology: https://510kreport.com/methodology