# K072187: Pioneer Lowtop Spinal Rod System

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Oct 12, 2007 after 67 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 4 generations back to K992147 (2000). 14 ancestors in all.
177 later devices descend from it; 4 cite it directly.
0 of 192 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070933: Lowtop Pedicle Screw System, Sanacor (2007) Summary page 1.
- K070973: Quantum Spinal System, Pioneer Surgical Technology (2007) Summary page 1.

## Most influential descendants
- K080518: Pioneer Surgical Technology Quantum Spinal System (2008), 174 descendants of its own
- K100297: Pass LP Spinal System (2010), 136 descendants of its own
- K110497: Pass LP Spinal System (2011), 133 descendants of its own
- K123138: Pass LP Spinal System (2013), 132 descendants of its own
- K080504: Pioneer Lowtop Spinal Rod System (2008), 92 descendants of its own

## Indications for use
The Pioneer LowTop Spinal Rod System is intended to provide immobilization 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 L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K072187
Methodology: https://510kreport.com/methodology