# K190567: KeYi Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Keyi Medical Device Technology Co., Ltd.
- Decided: May 8, 2019 after 63 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: 7 generations back to K040583 (2004). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012871: Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177, Interpore Cross Intl. (2001) Summary page 5.
- K111942: TSRH Spinal Systems, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 6.

## Indications for use
The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation 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.

Source page: https://510kreport.com/device/K190567
Methodology: https://510kreport.com/methodology