# K090224: Fortex Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: X-Spine Systems, Inc.
- Decided: Jul 30, 2009 after 181 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: 1 generation back to K052847 (2005). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052847: Capless Pedicle Screw System, X-Spine Systems, Inc. (2005) Summary page 2.
- K072282: Capless LI Pedicle Screw System, X-Spine Systems, Inc. (2007) Summary page 2.

## Most influential descendants
- K122163: Certex Spinal Implant System (2012), 2 descendants of its own
- K172548: Wiltrom Spinal Fixation System (2018), 1 descendant of its own
- K152132: X-spine Pedicle Screw System (2015), 1 descendant of its own
- K133094: Certex Oct Spinal Implant System (2013), 1 descendant of its own
- K202894: Wiltrom Spinal Fixation System (2020), 0 descendants of its own

## Indications for use
The Fortex Pedicle Screw System is 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 sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Fortex Pedicle Screw 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K090224
Methodology: https://510kreport.com/methodology