510(k) · Cleared

Cleared

CD Horizon Spinal System

K010249510(k) SpecialCleared Feb 23, 200128-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. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Feb 23, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 239 later devices descend from it.

Decided: Feb 23, 2001
Review: 28 days
Class: Class II
Product code: MNH
Recalls: None
Predicates: 0

239 later devices descend from it, 2 citing it directly.

This deviceK010249 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
Descendant · cites it directly · 237 of its ownK014296 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2002
Descendant · 2 generations on · 233 of its ownK090714 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
Descendant · 3 generations on · 128 of its ownK111510 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
Descendant · 4 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
Descendant · 3 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011

Showing 5 of 239 descendants. See all descendants

Descendants cleared per year

2002high 20 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 239 · See all

K014296CD Horizon Spinal SystemMedtronic Sofamor Danek · 2002 · cites it directly237descendants
K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009 · 2 generations on233descendants
K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 3 generations on128descendants
K121630Range Spinal SystemK2m, Inc. · 2012 · 4 generations on127descendants
K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 3 generations on106descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010249	CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2001	—
+1	K014296	CD Horizon Spinal System	Medtronic Sofamor Danek	2002	—
+2	K090714	Vertex Reconstruction System, Vertex Select Reconstruction System	Medtronic Sofamor Danek	2009	—
+3	K111510	CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2011	—
+4	K121630	Range Spinal System	K2m, Inc.	2012	—
+3	K110522	Vertex Reconstruction System, Vertex Select Reconstruction System	Medtronic Sofamor Danek USA, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2006	1	0
2007	1	0
2009	2	0
2011	3	0
2012	6	0
2013	13	0
2014	15	0
2015	16	0
2016	11	0
2017	18	0
2018	16	0
2019	12	0
2020	18	0
2021	12	0
2022	19	0
2023	20	0
2024	20	0
2025	18	0
2026	17	0

FIG. 1 — Lineage of K010249, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in MNH? 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? (239)

See all 239

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

Number	Device	Applicant	Decided	Descendants
K014296	CD Horizon Spinal System	Medtronic Sofamor Danek	2002	237
K063083	Modification to CD Horizon Spinal System	Medtronic Sofamor Danek, Inc.	2006	0

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?

Of its descendants, K014296 (Medtronic Sofamor Danek, 2002) has gone furthest, with 237 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

2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	123	0	18
2008	13	65	0	30
2009	13	151	7	45
2010	10	106	0	59
2011	17	171	0	107
2012	7	93	1	433
2013	10	124	1	464
2014	12	140	0	286
2015	10	99	0	152
2016	8	93	1	216
2017	0	—	0	174
2018	0	—	0	129
2019	0	—	0	403
2020	0	—	0	432
2021	0	—	0	531
2022	0	—	0	265
2023	0	—	0	121
2024	0	—	0	302
2025	0	—	0	89
2026	0	—	0	—

https://510kreport.com/device/K010249 · printed Nov 3, 2026

Cite this page

510(k) Report. “K010249: CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010249

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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