# K041167: Pioneer Surgical Technology Quantum Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Jul 23, 2004 after 80 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
No predicates in its family tree.
197 later devices descend from it; 6 cite it directly.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070551: Modification to: Pioneer Surgical Technology Quantum Spinal System (2007), 193 descendants of its own
- K070973: Quantum Spinal System (2007), 178 descendants of its own
- K072187: Pioneer Lowtop Spinal Rod System (2007), 177 descendants of its own
- K080518: Pioneer Surgical Technology Quantum Spinal System (2008), 174 descendants of its own
- K100297: Pass LP Spinal System (2010), 136 descendants of its own

## Recalls of this device
- Jul 29, 2005 · Not classified · Z-0021-06: Screw may be incorrectly etched as to length.

## Indications for use
The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a posterior pedicle screw system (TI - S2) 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 lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

Source page: https://510kreport.com/device/K041167
Methodology: https://510kreport.com/methodology