# K201788: EDEN Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Jmt Co., Ltd.
- Decided: Jun 23, 2022 after 723 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: 10 generations back to K950697 (1995). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143110: GALAXY MIS Screw System, Bm Korea (2015) Summary page 4.

## Most influential descendants
- K230762: EDEN Spinal Fixation MIS System (2023), 0 descendants of its own

## Indications for use
The EDEN Spinal Fixation System is intended to provide immobilization and stabilization of the posterior, non- cervical spine as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. The EDEN Spinal Fixation System can be used in an open approach and a percutaneous approach with MIS instrumentation.

Source page: https://510kreport.com/device/K201788
Methodology: https://510kreport.com/methodology