# K093771: Quantum/Streamline TL Mis Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Aug 10, 2010 after 245 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- 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: 6 generations back to K992147 (2000). 18 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080026: Quantum-Mis Cannulated System, Pioneer Surgical Technology (2008) Summary page 1.
- K072187: Pioneer Lowtop Spinal Rod System, Pioneer Surgical Technology (2007) Summary page 1.
- K080518: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2008) Summary page 1.
- K080504: Pioneer Lowtop Spinal Rod System, Pioneer Surgical Technology (2008) Summary page 1.

## Most influential descendants
- K130286: Streamline Mis Spinal Fixation System (2013), 7 descendants of its own
- 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

## Indications for use
The Streamline MIS Cannulated System is intended to provide imniobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-SI vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-S1) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K093771
Methodology: https://510kreport.com/methodology