510(k) Report

510(k) · Cleared

Cleared

Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System

K172107510(k) TraditionalCleared Aug 21, 201740-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 Aug 21, 2017 as substantially equivalent to K170255 (Spineology, Inc., 2017) and 5 other predicates after a 40-day review. Its family tree reaches back 21 generations to 2004. 1 of the 364 devices in its family, counting itself, has a Class I recall.

Decided
Aug 21, 2017
Review
40 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
6

Its longest line of descent runs back 21 generations to K040583 (2004). 363 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 364 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2017: 4 other ancestors2012: 7 other ancestors2011: 11 other ancestors2016: 1 other ancestor2015: 4 other ancestors2010: 16 other ancestors, 1 with a Class I recall12009: 17 other ancestors2008: 21 other ancestors2006: 23 other ancestors2003: 22 other ancestors2000: 21 other ancestors1997: 8 other ancestors2014: 3 other ancestors2013: 3 other ancestors2007: 20 other ancestors2005: 21 other ancestors2004: 25 other ancestors2002: 23 other ancestors2001: 24 other ancestors1999: 15 other ancestors1996: 10 other ancestors1995: 10 other ancestors1998: 17 other ancestors1994: 3 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor1978: 1 other ancestor1985: 1 other ancestor×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) K140010 · Fortress Pedicle Screw System · Spineology, Inc. · 2014K143403 · Threshold Pedicular Fixation System · Spineology, Inc. · 2014×3: 3 generations cleared close together, K153323 (2016), K160980 (2016), K161694 (2016) K170255 · Threshold™ V2 Pedicular Fixation System · Spineology, Inc. · 20171980199020002010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 24 other ancestors, 1 with a Class I recall13 generations back: 57 other ancestors4 generations back: 81 other ancestors5 generations back: 62 other ancestors6 generations back: 67 other ancestors7 generations back: 25 other ancestors8 generations back: 10 other ancestors9 generations back: 8 other ancestors10 generations back: 2 other ancestors11 generations back: 1 other ancestor K170255 · Threshold™ V2 Pedicular Fixation System · Spineology, Inc. · 2017K161694 · Threshold™ Pedicular Fixation System · Spineology, Inc. · 2016K160980 · Threshold Pedicular Fixation System, Palisade Pedicular Fixation System · Spineology, Inc. · 2016K153323 · Palisade Pedicular Fixation System · Spineology, Inc. · 2016K143403 · Threshold Pedicular Fixation System · Spineology, Inc. · 2014K140010 · Fortress Pedicle Screw System · Spineology, Inc. · 2014K132471 · 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 · 2004−20−15−10−50
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation…Spineology, Inc. · 2016
  4. 2 generations backK161694 Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016
  5. 1 generation backK170255 Threshold™ V2 Pedicular Fixation SystemSpineology, Inc. · 2017
  6. This deviceK172107 Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular…Spineology, Inc. · 2017
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 7 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 6 generations backK140010 Fortress Pedicle Screw SystemSpineology, Inc. · 2014
  17. 5 generations backK143403 Threshold Pedicular Fixation SystemSpineology, Inc. · 2014
  18. 4 generations backK153323 Palisade Pedicular Fixation SystemSpineology, Inc. · 2016
  19. 3 generations backK160980 Threshold Pedicular Fixation System, Palisade Pedicular Fixation…Spineology, Inc. · 2016
  20. 2 generations backK161694 Threshold™ Pedicular Fixation SystemSpineology, Inc. · 2016
  21. 1 generation backK170255 Threshold™ V2 Pedicular Fixation SystemSpineology, Inc. · 2017
  22. This deviceK172107 Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular…Spineology, Inc. · 2017

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−7K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−6K140010Fortress Pedicle Screw SystemSpineology, Inc.2014—
−5K143403Threshold Pedicular Fixation SystemSpineology, Inc.2014—
−4K153323Palisade Pedicular Fixation SystemSpineology, Inc.2016—
−3K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.2016—
−2K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.2016—
−1K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.2017—
0 (this device)K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System…Spineology, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199430
1995100
1996100
199780
1998170
1999150
2000210
2001240
2002230
2003220
2004250
2005210
2006230
2007200
2008210
2009170
2010161
2011110
201270
201330
201430
201540
201610
201740
FIG. 1 — Lineage of K172107, 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.

1 device in this family has a Class I recall. 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? (6)

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
*K170255Threshold™ V2 Pedicular Fixation System
Summary page 4
…duct Codes: NKB Regulatory Class: Class II Regulation Number: 21 CFR 888.3070 Panel: Orthopedic Predicate Devices Primary: K170255 Threshold™ V2 Pedicular Fixation System (Spineology Inc.) d Additional: K170251 Threshold™ Pedicular Fixation…
Spineology, Inc.2017—
*K170251Threshold™ Pedicular Fixation System
Summary page 4
…888.3070 Panel: Orthopedic Predicate Devices Primary: K170255 Threshold™ V2 Pedicular Fixation System (Spineology Inc.) d Additional: K170251 Threshold™ Pedicular Fixation System (Spineology Inc.) i K170268 Fortress ™ Pedicular Fixati…
Spineology, Inc.2017—
*K170268Fortress™ Pedicular Fixation System
Summary page 4
…hreshold™ V2 Pedicular Fixation System (Spineology Inc.) d Additional: K170251 Threshold™ Pedicular Fixation System (Spineology Inc.) i K170268 Fortress ™ Pedicular Fixation System (Spineology Inc.) ca…
Spineology, Inc.2017—
*K171438Palisade™ Pedicular Fixation System
Summary page 4
…tress ™ Pedicular Fixation System (Spineology Inc.) ca ur K171438 Palisade™ Pedicular Fixation System (Spineology Inc.)…
Spineology, Inc.2017—
*K120838Synthes Matrix System
Summary page 4
…8 Palisade™ Pedicular Fixation System (Spineology Inc.) l K120838 Synthes Matrix™ System (Synthes Spine) y…
Synthes Spine2012—
*K111478Stryker Spine Power Adaptor (Accessory Instrument)
Summary page 4
…hes Matrix™ System (Synthes Spine) y aF K111478 Power Adapter Instrument Accessory (Stryker Spine) s…
Stryker Corporation2011—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 37 of the 363 ancestors have a recall of any class; 1 has a Class I recall.

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. 2017, 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?

Spineology Pedicular Fixation Systems are intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Indications for use as stated in the FDA summary.

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/K172107 · printed Nov 4, 2026

Cite this page

510(k) Report. “K172107: Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172107

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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