# K201737: Posterior Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Reach Medical Instrument Co, Ltd.
- Decided: Jun 21, 2021 after 361 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: 13 generations back to K040583 (2004). 74 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130646: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.

## Most influential descendants
- K221745: Sterile Posterior Spinal Fixation System (2022), 0 descendants of its own

## Indications for use
The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion 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/K201737
Methodology: https://510kreport.com/methodology