# K192800: Streamline TL Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
- Decided: Jan 14, 2020 after 106 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.
3 later devices descend from it; 1 cites it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140696: Streamline TL Spinal Fixation System, Pioneer Surgical Technology, Inc. (2014) Summary page 5.
- K101790: Quantum Spinal System, Quantum Mis, Pioneer Surgical Technology (2011) Summary page 5.

## Most influential descendants
- K241892: Cortera™ Spinal Fixation System (2024), 2 descendants of its own
- K243946: EffortMed Spinal Fixation System (2025), 1 descendant of its own
- K254247: Osteomni Spinal Fixation System (2026), 0 descendants of its own

## Indications for use
The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation. Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann’s Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K192800
Methodology: https://510kreport.com/methodology