# K001668: Global Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: D.K.M. Co., Ltd.
- Decided: Oct 19, 2000 after 141 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 1 generation back to K992147 (2000). 1 ancestor in all.
450 later devices descend from it; 16 cite it directly.
0 of 452 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992147: Triple-Fix Spinal Fixation System, Advanced Spine Technology, Inc. (2000) Summary page 2.

## Most influential descendants
- K053573: GSS Pedicle Screw System (2006), 181 descendants of its own
- K033090: Icon Polyaxial Pedicle Screw System (2004), 180 descendants of its own
- K062513: Apex Spine System (2006), 179 descendants of its own
- K031455: Conklusion Pedicle Screw System (2003), 179 descendants of its own
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer (2010), 178 descendants of its own

## Indications for use
The Global Spinal Fixation System is a pedicle screw indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the GSFS is intended 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 spondylolisthesis with objective evidence of neurological impairement, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K001668
Methodology: https://510kreport.com/methodology