510(k) Report

510(k) · Cleared

Cleared

CD Horizon Spinal System

K050439510(k) SpecialCleared Mar 24, 200530-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

Medtronic Sofamor Danek, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 24, 2005 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 658 devices in its family, counting itself, has a Class I recall. 657 later devices descend from it.

Decided
Mar 24, 2005
Review
30 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
0

657 later devices descend from it, 5 citing it directly. 1 of the 658 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2009: 1 descendant cleared2014: 33 descendants cleared2013: 24 descendants cleared2016: 37 descendants cleared2015: 36 descendants cleared2022: 48 descendants cleared2011: 4 descendants cleared2010: 2 descendants cleared2012: 14 descendants cleared2018: 48 descendants cleared2025: 57 descendants cleared2023: 67 descendants cleared2024: 60 descendants cleared2021: 44 descendants cleared, 1 with a Class I recall12020: 46 descendants cleared2017: 44 descendants cleared2019: 38 descendants cleared2026: 54 descendants cleared20052010201520202025
  1. This deviceK050439 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2005
  2. Descendant · cites it directly · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  3. Descendant · 2 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  4. Descendant · 2 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  5. Descendant · 2 generations on · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
  6. Descendant · 2 generations on · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled

Showing 5 of 657 descendants. See all descendants

Descendants cleared per year

2009: 12010: 22011: 42012: 142013: 242014: 332015: 362016: 372017: 442018: 482019: 382020: 462021: 442022: 482023: 672024: 602025: 572026: 54
2009high 67 (2023) · low 1 (2009)2026

Class I recalls in this family

  • K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 657 · See all
  • K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · cites it directly656descendants
  • K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 2 generations on598descendants
  • K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 2 generations on597descendants
  • K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on597descendants
  • K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on596descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050439CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2005—
+1K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
+2K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
+2K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
+2K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2011—
+2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201020
201140
2012140
2013240
2014330
2015360
2016370
2017440
2018480
2019380
2020460
2021441
2022480
2023670
2024600
2025570
2026540
FIG. 1 — Lineage of K050439, 2005–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (657)

See all 657

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

NumberDeviceApplicantDecidedDescendants
K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2009656
K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013176
K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684
K143141CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201416
K143569CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201515

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.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K091974 (Medtronic Sofamor Danek USA, Inc., 2009) has gone furthest, with 656 descendants of its own.

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.

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—

More from Medtronic Sofamor Danek, Inc.

125 FDA decisions under this applicant name. See the company

  • K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc. · 2025
  • K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc. · 2025
  • K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
  • P060018/S005Prestige Cervical Disc SystemMedtronic Sofamor Danek, Inc. · 2016
  • P060018/S004PRESTIGE® Cervical DiscMedtronic Sofamor Danek, Inc. · 2016

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/K050439 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050439: CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050439

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026