510(k) Report

510(k) · Cleared

Cleared

Fortex Pedicle Screw System

K090224510(k) SpecialCleared Jul 30, 2009181-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

X-Spine Systems, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jul 30, 2009 as substantially equivalent to K052847 (X-Spine Systems, Inc., 2005) and 1 other predicate after a 181-day review. Its family tree reaches back 1 generation to 2005. 7 later devices descend from it.

Decided
Jul 30, 2009
Review
181 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K052847 (2005). 2 ancestors in all. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2012: 1 descendant cleared2015: 1 descendant cleared2018: 2 descendants cleared2016: 1 descendant cleared2013: 1 descendant cleared2020: 1 descendant clearedK052847 · Capless Pedicle Screw System · X-Spine Systems, Inc. · 200520052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants K052847 · Capless Pedicle Screw System · X-Spine Systems, Inc. · 20050
  1. Root · 1 generation backK052847 Capless Pedicle Screw SystemX-Spine Systems, Inc. · 2005
  2. This deviceK090224 Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2009
  3. Descendant · cites it directly · 2 of its ownK122163 Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012
  4. Descendant · cites it directly · 1 of its ownK172548 Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2018
  5. Descendant · cites it directly · 1 of its ownK152132 X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK133094 Certex Oct Spinal Implant SystemX-Spine Systems, Inc. · 2013
  7. Descendant · 2 generations on · 0 of its ownK202894 Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 12016: 12018: 22020: 1
2012high 2 (2018) · low 0 (2014)2026

Most influential descendants

Showing 5 of 7 · See all
  • K122163Certex Spinal Implant SystemX-Spine Systems, Inc. · 2012 · cites it directly2descendants
  • K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2018 · cites it directly1descendant
  • K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc. · 2015 · cites it directly1descendant
  • K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc. · 2013 · 2 generations on1descendant
  • K202894Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K052847Capless Pedicle Screw SystemX-Spine Systems, Inc.2005—
0 (this device)K090224Fortex Pedicle Screw SystemX-Spine Systems, Inc.2009—
+1K122163Certex Spinal Implant SystemX-Spine Systems, Inc.2012—
+1K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited2018—
+1K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.20151
+2K133094Certex Oct Spinal Implant SystemX-Spine Systems, Inc.2013—
+2K202894Wiltrom Spinal Fixation SystemWiltrom Corporation Limited2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201510
201610
201820
202010
FIG. 1 — Lineage of K090224, 2005–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052847Capless Pedicle Screw System
Summary page 2
…ation of medical devices, the Fortex Pedicle Screw System is substantially equivalent in indications and design principles to the predicate Capless Pedicle Screw System (K052847) and Capless LI Pedicle Screw System (K072282). Page 11 of 41 D…
X-Spine Systems, Inc.2005—
*K072282Capless LI Pedicle Screw System
Summary page 2
…crew System is substantially equivalent in indications and design principles to the predicate Capless Pedicle Screw System (K052847) and Capless LI Pedicle Screw System (K072282). Page 11 of 41 DEPARTMENT OF HEALTH & HUMAN SERVICES…
X-Spine Systems, Inc.20071

Also cleared against K052847: 3 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122163Certex Spinal Implant SystemX-Spine Systems, Inc.20122
K172548Wiltrom Spinal Fixation SystemWiltrom Corporation Limited20181
K152132X-spine Pedicle Screw SystemX-Spine Systems, Inc.20151

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K122163 (X-Spine Systems, Inc., 2012) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K052847.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—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 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…

Read the full statement (120 words)

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).

Indications for use as stated in the FDA summary.

Also cleared against K052847

3 other devices cite the same predicate.

  • K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010
  • K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
  • K083743Capsure PS SystemSpine Wave, Inc. · 2009

More from X-Spine Systems, Inc.

34 FDA decisions under this applicant name. See the company

  • K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc. · 20181 recall
  • K180153X-spine Cortical Bone Screw SystemX-Spine Systems, Inc. · 2018
  • K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc. · 20171 recall
  • K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc. · 20171 recall
  • K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K090224 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090224: Fortex Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090224

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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