# K251251: ChanPin Pedicle Screw Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Chanpin Medtak Co., Ltd.
- Decided: Jun 9, 2026 after 412 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: 18 generations back to K040583 (2004). 229 ancestors in all.
No later device cites it as a predicate yet.
0 of 230 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182416: NOVA Minimally Invasive System, Baui Biotech Co., Ltd. (2019) Summary page 5.

## Indications for use
The CHANPIN Pedicle Screw Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: A. Degenerative disc disease (defined as discogenic back pain with disc degeneration confirmed by medical history and radiographic studies) B. Spondylolisthesis C. Trauma D. Tumors E. Spinal stenosis F. Spinal deformities or curvatures (e.g., scoliosis, kyphosis, and/or lordosis) G. Failed previous fusion H. Pseudarthrosis The CHANPIN Pedicle Screw Spinal System is intended for adult patients only.

Source page: https://510kreport.com/device/K251251
Methodology: https://510kreport.com/methodology