# K083825: Eoi Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Expanding Orthopedics, Inc.
- Decided: Mar 19, 2009 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: 6 generations back to K040583 (2004). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063670: Modifications to CD Horizon Spinal System, Medtronic Sofamor Danek (2007) Summary page 1.

## Indications for use
The EOI Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to spinal fusion of the thoracic, lumbar, and/or sacral spine. The EOI Spinal System is limited to non-cervical, pedicle use and is specifically, indicated for treatment of one or more of the following acute and chronic instabilities or deformities: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (fracture or dislocation); 4. Deformities or curvatures (scoliosis, kyphosis, and/or lordosis); 5. Tumor; 6. Spinal stenosis; 7. Pseudoarthrosis; and/or 8. Failed previous fusion.

Source page: https://510kreport.com/device/K083825
Methodology: https://510kreport.com/methodology