# K172267: IRENE Thoracolumbar Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Zhengtian Medical Instrument Co., Ltd.
- Decided: Mar 6, 2018 after 222 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: 5 generations back to K951725 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111690: Devine Spinal System, Changzhou Orthmed Medical Instrument Co., Ltd. (2011) Summary page 4.

## Indications for use
IRENE Thoracolumbar Fixation System provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.

Source page: https://510kreport.com/device/K172267
Methodology: https://510kreport.com/methodology