510(k) Report

510(k) · Cleared

Cleared

CD Horizon Spinal System

K011508510(k) SpecialCleared Jun 12, 200127-day reviewClass II21 CFR 888.3050

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. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jun 12, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 715 devices in its family, counting itself, has a Class I recall. 714 later devices descend from it.

Decided
Jun 12, 2001
Review
27 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

714 later devices descend from it, 2 citing it directly. 1 of the 715 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 2 descendants cleared2005: 1 descendant cleared2012: 17 descendants cleared2025: 64 descendants cleared2011: 8 descendants cleared2014: 36 descendants cleared2010: 5 descendants cleared2013: 28 descendants cleared2009: 1 descendant cleared2018: 50 descendants cleared2024: 61 descendants cleared2022: 53 descendants cleared2023: 70 descendants cleared2019: 40 descendants cleared2015: 37 descendants cleared2020: 53 descendants cleared2016: 37 descendants cleared2017: 44 descendants cleared2021: 48 descendants cleared, 1 with a Class I recall12026: 59 descendants cleared200020052010201520202025
  1. This deviceK011508 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
  2. Descendant · cites it directly · 712 of its ownK041460 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2004
  3. Descendant · 2 generations on · 658 of its ownK042167 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  4. Descendant · 3 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  5. Descendant · 4 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  6. Descendant · 4 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011

Showing 5 of 714 descendants. See all descendants

Descendants cleared per year

2004: 22005: 12009: 12010: 52011: 82012: 172013: 282014: 362015: 372016: 372017: 442018: 502019: 402020: 532021: 482022: 532023: 702024: 612025: 642026: 59
2004high 70 (2023) · low 0 (2006)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 714 · See all
  • K041460CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2004 · cites it directly712descendants
  • K042167Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · 2 generations on658descendants
  • K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 3 generations on656descendants
  • K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 4 generations on598descendants
  • K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 4 generations on597descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011508CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2001—
+1K041460CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2004—
+2K042167Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
+3K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
+4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
+4K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200510
200910
201050
201180
2012170
2013280
2014360
2015370
2016370
2017440
2018500
2019400
2020530
2021481
2022530
2023700
2024610
2025640
2026590
FIG. 1 — Lineage of K011508, 2001–2026Source: 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? (714)

See all 714

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

NumberDeviceApplicantDecidedDescendants
K041460CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2004712
K043321Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek20050

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

What does this lineage say?

  • Of its descendants, K041460 (Medtronic Sofamor Danek USA, Inc., 2004) has gone furthest, with 712 descendants of its own.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

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125 FDA decisions under this applicant name. See the company

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Recent decisions in KWP

The KWP category page

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  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
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https://510kreport.com/device/K011508 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011508: 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/K011508

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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