510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Arsenal Spinal Fixation System

K133221510(k) TraditionalCleared Mar 13, 2014146-day reviewClass II21 CFR 888.3070Recalls 2

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 Mar 13, 2014 as substantially equivalent to K100685 (Alphatec Spine, Inc., 2010) and 1 other predicate after a 146-day review. Its family tree reaches back 13 generations to 2004. 150 later devices descend from it. It has been recalled 2 times.

Decided
Mar 13, 2014
Review
146 days
Class
Class II
Product code
NKB
Recalls
2
Predicates
2

Its longest line of descent runs back 13 generations to K040583 (2004). 104 ancestors in all, the oldest K841189 (1984). 150 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2009: 2 other ancestors2007: 3 other ancestors2005: 9 other ancestors2004: 17 other ancestors2011: 1 other ancestor2003: 9 other ancestors2002: 6 other ancestors2000: 9 other ancestors1999: 2 other ancestors1998: 6 other ancestors2008: 2 other ancestors2006: 5 other ancestors2001: 7 other ancestors1996: 5 other ancestors1997: 1 other ancestor1995: 3 other ancestors1994: 1 other ancestor1984: 1 other ancestor2015: 3 descendants cleared2016: 3 descendants cleared2014: 2 descendants cleared2017: 9 descendants cleared2018: 7 descendants cleared2019: 7 descendants cleared2024: 23 descendants cleared2020: 9 descendants cleared2021: 8 descendants cleared2022: 12 descendants cleared2025: 23 descendants cleared2026: 22 descendants cleared2023: 22 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. · 201319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 15 other ancestors4 generations back: 22 other ancestors5 generations back: 25 other ancestors6 generations back: 13 other ancestors7 generations back: 10 other ancestors 1 generation forward: 5 descendants2 generations forward: 16 descendants3 generations forward: 16 descendants4 generations forward: 22 descendants5 generations forward: 28 descendants6 generations forward: 31 descendants7 generations forward: 18 descendants8 generations forward: 12 descendants9 generations forward: 2 descendants K130646 · 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 · 2004−10−50+5
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations between
  3. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  4. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  5. 1 generation backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  6. This deviceK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014
  7. Descendant · cites it directly · 84 of its ownK143149 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  8. Descendant · cites it directly · 83 of its ownK152968 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  9. Descendant · cites it directly · 78 of its ownK142499 Reline SystemNu Vasive, Incorporated · 2014
  10. Descendant · 2 generations on · 77 of its ownK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  11. Descendant · cites it directly · 75 of its ownK161363 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
Show all 13 generations
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 1 generation backK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  14. This deviceK133221 Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2014

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

2014: 22015: 32016: 32017: 92018: 72019: 72020: 92021: 82022: 122023: 222024: 232025: 232026: 22
2014high 23 (2024) · low 2 (2014)2026

Most influential descendants

Showing 5 of 150 · See all
  • K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · cites it directly84descendants
  • K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015 · cites it directly83descendants
  • K142499Reline SystemNu Vasive, Incorporated · 2014 · cites it directly78descendants
  • K143684NuVasive Reline SystemNu Vasive, Incorporated · 2015 · 2 generations on77descendants
  • K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016 · cites it directly75descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−10K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−8K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−7K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−6K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−5K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−1K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
0 (this device)K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2014—
+1K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
+1K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2015—
+1K142499Reline SystemNu Vasive, Incorporated2014—
+2K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
+1K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199410
199530
199650
199710
199860
199920
200090
200170
200260
200390
2004170
200590
200650
200730
200820
200920
201020
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201420
201530
201630
201790
201870
201970
202090
202180
2022120
2023220
2024230
2025230
2026220
FIG. 1 — Lineage of K133221, 2004–2026Source: 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 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
*K100685Zodiac Polyaxial Spinal Fixation System
Summary page 2
…r allograft. Substantial Equivalence Claimed The Arsenal Spinal Fixation System is substantially equivalent to the Alphatec Spine, Inc., Zodiac® Spinal Fixation System (K 100685) for implants, instruments, indications for use, labeling, materials, design, technology and performance. In addition, the Arsena…
Alphatec Spine, Inc.2010—
*K130646CD Horizon Spinal System
Summary page 2
…hnology and performance. In addition, the Arsenal Spinal Fixation System is substantially equivalent to the Medtronic Sofamor Danek USA, Inc., CD Horizon" Spinal System (K 130646) for implants, instruments, and indications for use. Technical Characteristics The intended use and technological design feature…
Medtronic Sofamor Danek USA, Inc.2013—

Also cleared against K100685: 7 other devices →

What descends from it? (150)

See all 150

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

NumberDeviceApplicantDecidedDescendants
K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201584
K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201583
K142499Reline SystemNu Vasive, Incorporated201478
K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc.201675
K142737MAS PLIF Fixation systemNu Vasive, Incorporated20141

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

Recalls of this device

DateClassRecallRoot causeReason
May 5, 2017Class IIZ-2249-2017Under Investigation by firmAlphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
Oct 5, 2016Class IIZ-0592-2017Under Investigation by firmAlphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 16 of the 104 ancestors have a recall of any class.
  • Of its descendants, K143149 (Alphatec Spine, Inc., 2015) has gone furthest, with 84 descendants of its own.
  • 7 other devices also cite its predicate K100685.

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 Arsenal 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 (143 words)

The Arsenal 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 screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally the Arsenal Spinal Fixation System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. Pediatric pedicle screw fixation is limited to a posterior approach.

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

Indications for use as stated in the FDA summary.

Also cleared against K100685

7 other devices cite the same predicate.

  • K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited · 2017
  • K161516G Surgical Marksman MIS SystemG Surgical, LLC · 2016
  • K161363Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2016
  • K152968Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  • K143149Arsenal Spinal Fixation SystemAlphatec Spine, Inc. · 2015
  • K140678Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014

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/K133221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133221: Arsenal 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/K133221

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