# K073143: Modified Vertiflex Spinal Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Vertiflex, Inc.
- Decided: Apr 7, 2008 after 152 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: 9 generations back to K901587 (1990). 119 ancestors in all.
No later device cites it as a predicate yet.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062670: Vertiflex Spinal Screw System, Vertiflex (Tm), Incorporated (2007) Summary page 1.
- K991326: Isobar Semi-Rigid Spinal System, Scien'Tx USA, Inc. (1999) Summary page 1.
- K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004) Summary page 1.
- K061774: Nfix II Pedicle Screw System, N Spine, Inc. (2006) Summary page 1.
- K063670: Modifications to CD Horizon Spinal System, Medtronic Sofamor Danek (2007) Summary page 1.
- K060615: CD Horizon Spinal System, Medtronic Sofamor Danek (2006) Summary page 1.
- K052069: Protex Stabilization System with Additional Componentes, Globus Medical, Inc. (2005) Summary page 1.
- K072081: Zodiac Dynamo Semi-Rigid Spinal System, Alphatec Spine, Inc. (2007) Summary page 1.

## Indications for use
When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K073143
Methodology: https://510kreport.com/methodology