# K070933: Lowtop Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Sanacor
- Decided: Jun 13, 2007 after 71 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: 3 generations back to K992147 (2000). 8 ancestors in all.
178 later devices descend from it; 2 cite it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031455: Conklusion Pedicle Screw System, Signus Medical, LLC (2003) Summary page 1.
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 1.
- K061577: Ovaltwist Pedicle Screw System, Signus Medizintechnik GmbH (2006) Summary page 1.

## Most influential descendants
- 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
- K110497: Pass LP Spinal System (2011), 133 descendants of its own
- K123138: Pass LP Spinal System (2013), 132 descendants of its own

## Indications for use
The LowTop System is intended for posterior, non-cervical pedicle fixation for the following indications: * Spondylolisthesis * Trauma (i.e., fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 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/K070933
Methodology: https://510kreport.com/methodology