# K192396: Streamline MIS Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Nov 26, 2019 after 84 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 K901587 (1990). 144 ancestors in all.
No later device cites it as a predicate yet.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130286: Streamline Mis Spinal Fixation System, Pioneer Surgical Technology, Inc. (2013) Summary page 4.
- K140696: Streamline TL Spinal Fixation System, Pioneer Surgical Technology, Inc. (2014) Summary page 4.

## Indications for use
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2 or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (DDD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Streamline MIS Instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Source page: https://510kreport.com/device/K192396
Methodology: https://510kreport.com/methodology