510(k) Report

510(k) · Cleared

Cleared

Kodiak Spinal Fixation System

K181677510(k) TraditionalCleared Aug 9, 201844-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

Alphatec Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Aug 9, 2018 as substantially equivalent to K161363 (Alphatec Spine, Inc., 2016) and 4 other predicates after a 44-day review. Its family tree reaches back 17 generations to 2004. 70 later devices descend from it.

Decided
Aug 9, 2018
Review
44 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
5

Its longest line of descent runs back 17 generations to K040583 (2004). 266 ancestors in all, the oldest K781443 (1978). 70 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 1 other ancestor2013: 2 other ancestors2007: 12 other ancestors2015: 1 other ancestor2014: 3 other ancestors2012: 1 other ancestor2010: 8 other ancestors2006: 14 other ancestors2004: 25 other ancestors2003: 21 other ancestors2001: 22 other ancestors2011: 6 other ancestors2009: 5 other ancestors2008: 17 other ancestors2005: 17 other ancestors2000: 20 other ancestors1999: 8 other ancestors1998: 15 other ancestors1996: 6 other ancestors2002: 19 other ancestors1997: 5 other ancestors1995: 7 other ancestors1994: 2 other ancestors1984: 1 other ancestor1985: 1 other ancestor1978: 1 other ancestor1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2019: 1 descendant cleared2020: 4 descendants cleared2022: 7 descendants cleared2024: 15 descendants cleared2021: 2 descendants cleared2026: 15 descendants cleared2025: 16 descendants cleared2023: 10 descendants 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) K130646 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K133221 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2014 · recalledK143149 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2015×2: 2 generations cleared close together, K152968 (2015), K161363 (2016) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 11 other ancestors3 generations back: 32 other ancestors4 generations back: 37 other ancestors5 generations back: 53 other ancestors6 generations back: 43 other ancestors7 generations back: 34 other ancestors8 generations back: 15 other ancestors9 generations back: 12 other ancestors10 generations back: 9 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 12 descendants5 generations forward: 21 descendants6 generations forward: 19 descendants7 generations forward: 1 descendant K161363 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2016K152968 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2015K143149 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2015K133221 · Arsenal Spinal Fixation System · Alphatec Spine, Inc. · 2014 · recalledK130646 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K113174 · 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+5
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations between
  3. 3 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  4. 2 generations backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  5. 1 generation backK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
  6. This deviceK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
  7. Descendant · cites it directly · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
  8. Descendant · cites it directly · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
  9. Descendant · 2 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
  10. Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
  11. Descendant · 4 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Show all 17 generations
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 5 generations backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  14. 4 generations backK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014 · Recalled
  15. 3 generations backK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  16. 2 generations backK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  17. 1 generation backK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
  18. This deviceK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2019: 12020: 42021: 22022: 72023: 102024: 152025: 162026: 15
2019high 16 (2025) · low 1 (2019)2026

Most influential descendants

Showing 5 of 70 · See all
  • K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · cites it directly69descendants
  • K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · cites it directly61descendants
  • K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 2 generations on59descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
  • K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 4 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−14K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−12K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−10K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−9K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−8K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−7K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−6K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−5K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−4K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20142
−3K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
−2K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
−1K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2016—
0 (this device)K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.2018—
+1K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2019—
+1K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.2020—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.2021—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199320
199420
199570
199660
199750
1998150
199980
2000200
2001220
2002190
2003210
2004250
2005170
2006140
2007120
2008170
200950
201080
201160
201210
201320
201430
201510
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202040
202120
202270
2023100
2024150
2025160
2026150
FIG. 1 — Lineage of K181677, 2004–2026Source: 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? (5)

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
*K161363Arsenal Spinal Fixation System
Summary page 4
…510(k) Product Code Trade Name Manufacturer Primary Predicate Device NKB, OSH, MNI, K161363 Arsenal Spinal Fixation System Alphatec Spine MNH, KWP Additional Pre…
Alphatec Spine, Inc.2016—
*K152968Arsenal Spinal Fixation System
Summary page 4
…Arsenal Spinal Fixation System Alphatec Spine MNH, KWP Additional Predicate Devices NKB, OSH, MNI, K152968 Arsenal Spinal Fixation System Alphatec Spine MNH, KWP K…
Alphatec Spine, Inc.2015—
*K071890Zodiac 4.0 Polyaxial Spinal Fixation System
Summary page 4
…Arsenal Spinal Fixation System Alphatec Spine MNH, KWP KWP, MNI, Zodiac Polyaxial Spinal Fixation K071890 Alphatec Spine MNH System…
Alphatec Spine, Inc.20071
*K160775Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Summary page 4
…Alphatec Spine MNH System NKB, MNI, Lancer Open Pedicle Screw K160775 Choice Spine LP MNH, KWP System…
Choicespine, LP2016—
*K131802Expedium, Viper. Viper 2 Spine System
Summary page 4
…60775 Choice Spine LP MNH, KWP System KWP, KWQ, K131802 NKB, OSH, MNI, Expedium Spine System DePuy Spine MNH…
Depuy Spine, A Johnson & Johnson Company2013—

Also cleared against K161363: 8 other devices →

What descends from it? (70)

See all 70

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

NumberDeviceApplicantDecidedDescendants
K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969
K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061
K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200

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 14 years and passes through 4 companies; a new generation was cleared every 5 months on median.
  • 27 of the 266 ancestors have a recall of any class.
  • Of its descendants, K192938 (Alphatec Spine, Inc., 2019) has gone furthest, with 69 descendants of its own.
  • 8 other devices also cite its predicate K161363.

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. 2018, 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 Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor…

Read the full statement (162 words)

The Kodiak Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients 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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Kodiak Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Kodiak Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

The Kodiak Spinal Fixation System is intended to be used with autograft and/or allograft.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K161363

8 other devices cite the same predicate.

  • K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc. · 2024
  • K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
  • K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
  • K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc. · 2020
  • K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
  • K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018

More from Alphatec Spine, Inc.

96 FDA decisions under this applicant name. See the company

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026
  • K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc. · 2026
  • K253615Invictus Bands SystemAlphatec Spine, Inc. · 2026
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)Alphatec Spine, Inc. · 2026

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/K181677 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181677: Kodiak Spinal 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/K181677

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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