# K061577: Ovaltwist Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Sep 14, 2006 after 99 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
No predicates in its family tree.
183 later devices descend from it; 4 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070933: Lowtop Pedicle Screw 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
- K110497: Pass LP Spinal System (2011), 133 descendants of its own

## Indications for use
The OvalTwist 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

Source page: https://510kreport.com/device/K061577
Methodology: https://510kreport.com/methodology