510(k) Report

510(k) · Cleared

Cleared

Seneka II Polyscrew Pedicle Fixation System

K153525510(k) TraditionalCleared Jan 28, 201650-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

Senecka Spine · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jan 28, 2016 as substantially equivalent to K151849 (Senecka Spine, 2015) and 2 other predicates after a 50-day review. Its family tree reaches back 18 generations to 2004.

Decided
Jan 28, 2016
Review
50 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 18 generations to K040583 (2004). 350 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 2 other ancestors2001: 29 other ancestors2014: 2 other ancestors2011: 13 other ancestors2003: 22 other ancestors2002: 20 other ancestors2000: 18 other ancestors1999: 14 other ancestors2013: 3 other ancestors2012: 7 other ancestors2010: 12 other ancestors2009: 12 other ancestors1998: 16 other ancestors1997: 8 other ancestors1996: 10 other ancestors1994: 3 other ancestors2008: 18 other ancestors2007: 15 other ancestors2006: 20 other ancestors2005: 29 other ancestors2004: 36 other ancestors1995: 10 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1984: 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. · 2012×3: 3 generations cleared close together, K131321 (2013), K132471 (2013), K140276 (2014) K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K151216 · Everest Spinal System · K2m, Inc. · 20151980199020002010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 8 other ancestors3 generations back: 18 other ancestors4 generations back: 65 other ancestors5 generations back: 71 other ancestors6 generations back: 54 other ancestors7 generations back: 46 other ancestors8 generations back: 46 other ancestors9 generations back: 16 other ancestors10 generations back: 5 other ancestors11 generations back: 1 other ancestor K151216 · Everest Spinal System · K2m, Inc. · 2015K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K140276 · CD Horizon Spinal System · Medtronic Sofamor Danek · 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 · 2004−15−10−50
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  4. 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  5. 1 generation backK151216 Everest Spinal SystemK2m, Inc. · 2015
  6. This deviceK153525 Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine · 2016
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 4 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 3 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 2 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 1 generation backK151216 Everest Spinal SystemK2m, Inc. · 2015
  19. This deviceK153525 Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−4K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−3K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−2K142381Xia 3 Spinal SystemStryker Corp.2014—
−1K151216Everest Spinal SystemK2m, Inc.2015—
0 (this device)K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199430
1995100
1996100
199780
1998160
1999140
2000180
2001290
2002200
2003220
2004360
2005290
2006200
2007150
2008180
2009120
2010120
2011130
201270
201330
201420
201520
FIG. 1 — Lineage of K153525, 2004–2016Source: 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? (3)

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
*K151849Seneka I Polyscrew Pedicle Fixation System
Summary page 4
…e Device(s): The Seneka II Polyscrew Pedicle Fixation System is substantially equivalent to the primary predicate device which is the Seneka I System from Senecka Spine (K151849). Additional predicate devices include Scien’tx USA Inc. ISOBAR Spinal System (K013444) and the K2M Inc. Everest Spinal System (K…
Senecka Spine2015—
*K013444Isobar Spinal System
Summary page 4
…t to the primary predicate device which is the Seneka I System from Senecka Spine (K151849). Additional predicate devices include Scien’tx USA Inc. ISOBAR Spinal System (K013444) and the K2M Inc. Everest Spinal System (K151216).…
Scien'Tx USA, Inc.2001—
*K151216Everest Spinal System
Summary page 4
…neka I System from Senecka Spine (K151849). Additional predicate devices include Scien’tx USA Inc. ISOBAR Spinal System (K013444) and the K2M Inc. Everest Spinal System (K151216). K153525 - Page 2 of 2 P…
K2m, Inc.2015—

What descends from it?

No later submission names this one as a predicate yet.

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 12 years and passes through 7 companies; a new generation was cleared every 5 months on median.
  • 37 of the 350 ancestors have a recall of any class.

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. 2016, 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 Seneka II Polyscrew Pedicle Fixation System is intended for posterior non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (DDD) (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…

Read the full statement (98 words)

The Seneka II Polyscrew Pedicle Fixation System is intended for posterior non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (DDD) (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 failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system the Seneka II Polyscrew Pedicle Fixation System may also be used for the same indications as an adjunct to fusion.

Indications for use as stated in the FDA summary.

More from Senecka Spine

2 FDA decisions under this applicant name. See the company

  • K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine · 2015

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/K153525 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153525: Seneka II Polyscrew Pedicle Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153525

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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