# K130286: Streamline Mis Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Apr 1, 2013 after 55 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K901587 (1990). 75 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111502: Streamline TL Spinal System, Pioneer Surgical Technology, Inc. (2011) Summary page 1.
- K101790: Quantum Spinal System, Quantum Mis, Pioneer Surgical Technology (2011) Summary page 1.
- K093771: Quantum/Streamline TL Mis Spinal System, Pioneer Surgical Technology (2010) Summary page 1.
- K022949: Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K131100: Streamline TL Spinal System (2013), 6 descendants of its own
- K140696: Streamline TL Spinal Fixation System (2014), 5 descendants of its own
- K192800: Streamline TL Spinal Fixation System (2020), 3 descendants of its own
- K241892: Cortera™ Spinal Fixation System (2024), 2 descendants of its own
- K243946: EffortMed Spinal Fixation System (2025), 1 descendant of its own

## Recalls of this device
- Jun 14, 2013 · Class II · Z-2616-2014: The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.

## Indications for use
The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T I-S2. Pedicle screw fixationis limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all of 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. The 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/K130286
Methodology: https://510kreport.com/methodology