510(k) Report

510(k) · Cleared

Cleared

Modification to CD Horizon Spinal System

K000094510(k) SpecialCleared Feb 8, 200026-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 USA, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 8, 2000 after a 26-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 989 devices in its family, counting itself, has a Class I recall. 988 later devices descend from it.

Decided
Feb 8, 2000
Review
26 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
0

988 later devices descend from it, 3 citing it directly. 1 of the 989 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 9 descendants cleared2004: 1 descendant cleared2022: 73 descendants cleared2014: 49 descendants cleared2007: 5 descendants cleared2021: 60 descendants cleared, 1 with a Class I recall12008: 8 descendants cleared2013: 50 descendants cleared2020: 68 descendants cleared2016: 54 descendants cleared2009: 12 descendants cleared2011: 15 descendants cleared2010: 8 descendants cleared2018: 62 descendants cleared2006: 7 descendants cleared2012: 32 descendants cleared2023: 91 descendants cleared2015: 55 descendants cleared2019: 49 descendants cleared2017: 58 descendants cleared2024: 77 descendants cleared2025: 74 descendants cleared2026: 71 descendants cleared200020052010201520202025
  1. This deviceK000094 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2000
  2. Descendant · cites it directly · 987 of its ownK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  3. Descendant · cites it directly · 880 of its ownK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  4. Descendant · cites it directly · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  5. Descendant · 2 generations on · 822 of its ownK060615 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · Recalled
  6. Descendant · 2 generations on · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007

Showing 5 of 988 descendants. See all descendants

Descendants cleared per year

2004: 12005: 92006: 72007: 52008: 82009: 122010: 82011: 152012: 322013: 502014: 492015: 552016: 542017: 582018: 622019: 492020: 682021: 602022: 732023: 912024: 772025: 742026: 71
2004high 91 (2023) · low 1 (2004)2026

Class I recalls in this family

  • K211616 ExcelsiusHub5 generations on · 2021

Most influential descendants

Showing 5 of 988 · See all
  • K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly987descendants
  • K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly880descendants
  • K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · cites it directly870descendants
  • K060615CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · 2 generations on822descendants
  • K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 2 generations on821descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000094Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2000—
+1K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
+1K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
+1K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
+2K060615CD Horizon Spinal SystemMedtronic Sofamor Danek200634
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200590
200670
200750
200880
2009120
201080
2011150
2012320
2013500
2014490
2015550
2016540
2017580
2018620
2019490
2020680
2021601
2022730
2023910
2024770
2025740
2026710
FIG. 1 — Lineage of K000094, 2000–2026Source: 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), 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (988)

See all 988

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

NumberDeviceApplicantDecidedDescendants
K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2004987
K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005880
K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005870

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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K042025 (Medtronic Sofamor Danek, Inc., 2004) has gone furthest, with 987 descendants of its own.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

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  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K000094 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000094: Modification to CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000094

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026