# K120832: Fortex Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: X-Spine Systems, Inc.
- Decided: Oct 23, 2012 after 218 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fortex Pedicle Screw System: named in the summary without a submission number

## Most influential descendants
- K152132: X-spine Pedicle Screw System (2015), 1 descendant of its own
- K180655: Viking Lumbar Polyaxial Screw System (2018), 0 descendants of its own
- K180153: X-spine Cortical Bone Screw System (2018), 0 descendants of its own

## Recalls of this device
- Apr 12, 2017 · Class II · Z-1884-2017: The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.
- Apr 7, 2015 · Class II · Z-1823-2015: The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
- Mar 11, 2015 · Class II · Z-1512-2015: One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

## Indications for use
The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L-5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L-3 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/K120832
Methodology: https://510kreport.com/methodology