# K121568: Dali Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Accel Spine
- Decided: Sep 21, 2012 after 115 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: 11 generations back to K990745 (1999). 114 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120270: Venus Spinal Fixation System, L&K BIOMED Co., Ltd. (2012) Summary page 1.
- 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.
- K091717: Any Plus Spinal Fixation System, GS Medical Co., Ltd. (2010) Summary page 1.
- K062513: Apex Spine System, Spinecraft, Inc. (2006) Summary page 1.
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer, Spinecraft, Inc. (2010) Summary page 1.
- K102488: Apex Spine System W/ Cocr Rods, Spinecraft, LLC (2010) Summary page 1.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 1.
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 1.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009) Summary page 1.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1.

## Most influential descendants
- K173185: SEURAT™ Universal Pedicle Screw System (2018), 0 descendants of its own

## Indications for use
The Dali Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated 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/K121568
Methodology: https://510kreport.com/methodology