# K080504: Pioneer Lowtop Spinal Rod System

- Pathway: 510(k) (Special)
- Applicant: Pioneer Surgical Technology
- Decided: Mar 20, 2008 after 24 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: 5 generations back to K992147 (2000). 15 ancestors in all.
92 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072187: Pioneer Lowtop Spinal Rod System, Pioneer Surgical Technology (2007) Summary page 1.
- K070933: Lowtop Pedicle Screw System, Sanacor (2007) 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.

## Most influential descendants
- K093692: Quantum/ Streamline Spinal System Model 02-Series and 10-Series (2010), 90 descendants of its own
- K110692: Streamline TL Spinal System (2011), 89 descendants of its own
- K111502: Streamline TL Spinal System (2011), 88 descendants of its own
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems (2014), 82 descendants of its own
- K160775: Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (2016), 73 descendants of its own

## Indications for use
The Pioneer LowTop Spinal Rod System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (TI - S2), a posterior hook and sacral/iliac screw fixation system 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/K080504
Methodology: https://510kreport.com/methodology