# K222031: Spinal Inner Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
- Decided: Oct 28, 2022 after 109 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: 4 generations back to K031655 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143013: Spinal Inner Fixation System, Changzhou Dingjian Medical Appliance Co., Ltd. (2015) Summary page 4.

## Indications for use
Spinal Inner Fixation System is intended for posterior, non-cervical, pedicle fixation 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 device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft.

Source page: https://510kreport.com/device/K222031
Methodology: https://510kreport.com/methodology