# K182544: AccelFix Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: May 28, 2019 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: 13 generations back to K990745 (1999). 151 ancestors in all.
10 later devices descend from it; 7 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171813: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System, L&K BIOMED Co., Ltd. (2017) Summary page 4.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 4.
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 4.
- K011437: Synergy 4.0 MM, 4.5 MM VLS Screws, Interpore Cross Intl. (2001) Summary page 4.
- K172546: AnyPlus® Spinal Fixation System, GS Medical Co., Ltd. (2017) Summary page 4.
- K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549), U&I Corp. (2009) Summary page 4.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 4.
- K053573: GSS Pedicle Screw System, GS Medical Co., Ltd. (2006) Summary page 4.
- K161766: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2016) Summary page 4.

## Most influential descendants
- 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
- 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

## Indications for use
The AccelFix Spinal Fixation System is intended for use as a posterior pedicle screw system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5), to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: 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/K182544
Methodology: https://510kreport.com/methodology