# K230762: EDEN Spinal Fixation MIS System

- Pathway: 510(k) (Special)
- Applicant: Jmt Co., Ltd.
- Decided: Jun 15, 2023 after 87 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 K950697 (1995). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201788: EDEN Spinal Fixation System, Jmt Co., Ltd. (2022) Summary page 4.

## Indications for use
The EDEN Spinal Fixation MIS 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 of discogenic 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 MIS System can be used in an open approach and a percutaneous approach.

Source page: https://510kreport.com/device/K230762
Methodology: https://510kreport.com/methodology