# K252730: Fule Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Fule Science & Technology Development Co., Ltd.
- Decided: Oct 24, 2025 after 57 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 K901587 (1990). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111883: Smartloc Spinal Fixation System, A-Spine Asia, Co., Ltd. (2011) Summary page 5.

## Indications for use
The Fule Spinal Fixation System is a thoracolumbosacral pedicle screw system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments (T1 to S2) as an adjunct to fusion in skeletally mature patients for the following acute and chronic instabilities or deformities: degenerative disc disease (as confirmed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.

Source page: https://510kreport.com/device/K252730
Methodology: https://510kreport.com/methodology