510(k) · Cleared
Recalled · Class II · 2017Fortex Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
X-Spine Systems, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Oct 23, 2012 after a 218-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 23, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 3
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK120832 Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK152132 X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015 · Recalled
- Descendant · cites it directly · 0 of its ownK180655 Viking Lumbar Polyaxial Screw SystemPresidio Surgical · 2018
- Descendant · 2 generations on · 0 of its ownK180153 X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120832 | Fortex Pedicle Screw System | X-Spine Systems, Inc. | 2012 | — |
| +1 | K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015 | 1 |
| +1 | K180655 | Viking Lumbar Polyaxial Screw System | Presidio Surgical | 2018 | — |
| +2 | K180153 | X-spine Cortical Bone Screw System | X-Spine Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Fortex Pedicle Screw System Named without a submission number | |
| † | K080792 | K2M Cocr Rod | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 12, 2017 | Class II | Z-1884-2017 | Labeling mix-ups | 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 | Other | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. |
| Mar 11, 2015 | Class II | Z-1512-2015 | Nonconforming Material/Component | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152132 (X-Spine Systems, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (119 words)
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120832 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120832: Fortex Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120832
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026