# K101790: Quantum Spinal System, Quantum Mis

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Mar 7, 2011 after 252 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: 7 generations back to K040583 (2004). 46 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080518: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2008) Summary page 1.
- K080026: Quantum-Mis Cannulated System, Pioneer Surgical Technology (2008) Summary page 1.
- K070973: Quantum Spinal System, Pioneer Surgical Technology (2007) Summary page 1.
- K070551: Modification to: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2007) Summary page 1.
- K041167: Pioneer Surgical Technology Quantum Spinal System, Pioneer Surgical Technology (2004) Summary page 1.
- K060638: Dynesys Spinal System with HA Coated Screws, Zimmer Spine, Inc. (2006) Summary page 1.
- K091797: TSRH Spinal System, Medtronic Sofamor Danek (2010) 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 Quantum-MIS Cannulated System is intended to provide immobilization and stabilization of spinal segments iii 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 spondlylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and /or lordosis), spinal turnor, and failed previous fusion (pseudoarthirosis). In additioii, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L-3-S 1) with removal of the implants after the -attainment of a solid fusion. The Quantum Spinal System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw system (TI - S2), posterior hook (TI-L5) sacral/iliac screw fixatioii or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: 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 lqrdosis, Scheuermann's Disease), tumnor, stenosis, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K101790
Methodology: https://510kreport.com/methodology