510(k) Report

510(k) · Cleared

Cleared

Fortress Pedicle Screw System

K140010510(k) TraditionalCleared Apr 23, 2014111-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

Spineology, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Apr 23, 2014 as substantially equivalent to K082509 (Korea Bone Bank Co., Ltd., 2008) and 1 other predicate after a 111-day review. Its family tree reaches back 15 generations to 2004. 11 later devices descend from it.

Decided
Apr 23, 2014
Review
111 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
2

Its longest line of descent runs back 15 generations to K040583 (2004). 113 ancestors in all, the oldest K781443 (1978). 11 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 5 other ancestors2011: 2 other ancestors2010: 3 other ancestors2006: 7 other ancestors2004: 17 other ancestors2003: 9 other ancestors2009: 1 other ancestor2005: 11 other ancestors2000: 14 other ancestors2007: 3 other ancestors2002: 6 other ancestors2001: 9 other ancestors1999: 2 other ancestors1998: 3 other ancestors1997: 1 other ancestor1996: 3 other ancestors1978: 1 other ancestor1984: 1 other ancestor2015: 1 descendant cleared2016: 3 descendants cleared2017: 6 descendants cleared2014: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×2: 2 generations cleared close together, K131321 (2013), K132471 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 20 other ancestors4 generations back: 39 other ancestors5 generations back: 20 other ancestors6 generations back: 5 other ancestors7 generations back: 7 other ancestors 1 generation forward: 5 descendants2 generations forward: 5 descendants3 generations forward: 1 descendant K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations between
  3. 3 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  4. 2 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  5. 1 generation backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  6. This deviceK140010 Fortress Pedicle Screw SystemSpineology, Inc. · 2014
  7. Descendant · cites it directly · 8 of its ownK152148 Fortress Pedicular Fixation SystemSpineology, Inc. · 2015
  8. Descendant · cites it directly · 8 of its ownK143403 Threshold Pedicular Fixation SystemSpineology, Inc. · 2014
  9. Descendant · cites it directly · 7 of its ownK153323 Palisade Pedicular Fixation SystemSpineology, Inc. · 2016
  10. Descendant · 2 generations on · 6 of its ownK160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation…Spineology, Inc. · 2016
  11. Descendant · cites it directly · 3 of its ownK161694 Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016
Show all 15 generations
  1. Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 3 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 2 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 1 generation backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. This deviceK140010 Fortress Pedicle Screw SystemSpineology, Inc. · 2014

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 32017: 6
2014high 6 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all
  • K152148Fortress Pedicular Fixation SystemSpineology, Inc. · 2015 · cites it directly8descendants
  • K143403Threshold Pedicular Fixation SystemSpineology, Inc. · 2014 · cites it directly8descendants
  • K153323Palisade Pedicular Fixation SystemSpineology, Inc. · 2016 · cites it directly7descendants
  • K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc. · 2016 · 2 generations on6descendants
  • K161694Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−14K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−12K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−10K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−8K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−7K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−6K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−5K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−1K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
0 (this device)K140010Fortress Pedicle Screw SystemSpineology, Inc.2014—
+1K152148Fortress Pedicular Fixation SystemSpineology, Inc.2015—
+1K143403Threshold Pedicular Fixation SystemSpineology, Inc.2014—
+1K153323Palisade Pedicular Fixation SystemSpineology, Inc.2016—
+2K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.2016—
+1K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199630
199710
199830
199920
2000140
200190
200260
200390
2004170
2005110
200670
200730
200850
200910
201030
201120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201630
201760
FIG. 1 — Lineage of K140010, 2004–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NKB device

  1. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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
*K082509Eos Spinal System
Summary page 1
…roduct Classification Class Ill per 21 CFR 888.3070, Product Codes MNI, MNH, and NKB and Code: KBB EOS Pedicle Screw System (K082509) and CD Horizon Spinal Predicate Device(s): Fixation System from Medtronic Sofamor Danek (most recent clearance is…
Korea Bone Bank Co., Ltd.2008—
*K132471CD Horizon Spinal System
Summary page 1
…ew System (K082509) and CD Horizon Spinal Predicate Device(s): Fixation System from Medtronic Sofamor Danek (most recent clearance is _________________K132471) The Spineology FortressTm Pedicle Screw System consists of screws (titanium)…
Medtronic Sofamor Danek USA, Inc.2013—

Also cleared against K082509: 3 other devices →

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K152148Fortress Pedicular Fixation SystemSpineology, Inc.20158
K143403Threshold Pedicular Fixation SystemSpineology, Inc.20148
K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167
K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163
K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171

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?

  • The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 14 of the 113 ancestors have a recall of any class.
  • Of its descendants, K152148 (Spineology, Inc., 2015) has gone furthest, with 8 descendants of its own.
  • 3 other devices also cite its predicate K082509.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

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

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, 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
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The Spineology Fortressm Pedicle Screw System is intended for posterior, nan-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; cuvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Indications for use as stated in the FDA summary.

Also cleared against K082509

3 other devices cite the same predicate.

  • K102574Palla M Spinal SystemKorea Bone Bank Co., Ltd. · 2011
  • K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
  • K100706Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2010

More from Spineology, Inc.

54 FDA decisions under this applicant name. See the company

  • K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2025
  • K251943Spineology Navigation InstrumentsSpineology, Inc. · 2025
  • K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
  • K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
  • K213876Spineology Navigation InstrumentsSpineology, Inc. · 2022

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K140010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140010: Fortress Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140010

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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