510(k) · Cleared
ClearedCD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 17, 2005 as substantially equivalent to K041862 (Medtronic Sofamor Danek, 2004) and 3 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1999. 1 of the 797 devices in its family, counting itself, has a Class I recall. 786 later devices descend from it.
- Decided
- May 17, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K981676 (1999). 10 ancestors in all. 786 later devices descend from it, 4 citing it directly. 1 of the 797 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 2 generations backK041862 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK050079 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- This deviceK050981 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · cites it directly · 778 of its ownK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 776 of its ownK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · cites it directly · 663 of its ownK090390 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
Showing 5 of 786 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 786 · See all- K053101CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · cites it directly778descendants
- K091442CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · cites it directly776descendants
- K090390CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · cites it directly663descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 2 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 3 generations on598descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −2 | K041862 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K050079 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| 0 (this device) | K050981 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +1 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +1 | K090390 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +3 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 25 | 0 |
| 2014 | 35 | 0 |
| 2015 | 38 | 0 |
| 2016 | 42 | 0 |
| 2017 | 46 | 0 |
| 2018 | 51 | 0 |
| 2019 | 43 | 0 |
| 2020 | 55 | 0 |
| 2021 | 57 | 1 |
| 2022 | 68 | 0 |
| 2023 | 85 | 0 |
| 2024 | 77 | 0 |
| 2025 | 70 | 0 |
| 2026 | 65 | 0 |
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.
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
What was it cleared against? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041862 | CD Horizon Spinal SystemSummary page 2…alysis, was provided which demonstrated the subject components to be substantially equivalent to the previously cleared CD HORIZON®D Spinal System connectors cleared in (K041862, K050079, K040583 AND K043488) for use for the identical indications.… | 2004 |
| * | K050079 | CD Horizon Spinal SystemSummary page 2…as provided which demonstrated the subject components to be substantially equivalent to the previously cleared CD HORIZON®D Spinal System connectors cleared in (K041862, K050079, K040583 AND K043488) for use for the identical indications.… | 2005 |
| * | K040583 | Modification to: CD Horizon Spinal SystemSummary page 2…ed which demonstrated the subject components to be substantially equivalent to the previously cleared CD HORIZON®D Spinal System connectors cleared in (K041862, K050079, K040583 AND K043488) for use for the identical indications.… | 2004 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 2…onstrated the subject components to be substantially equivalent to the previously cleared CD HORIZON®D Spinal System connectors cleared in (K041862, K050079, K040583 AND K043488) for use for the identical indications.… | 2005 |
What descends from it? (786)
See all 7864 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K053101 (Medtronic Sofamor Danek, 2006) has gone furthest, with 778 descendants of its own.
- 3 other devices also cite its predicate K041862.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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 in a…
Read the full statement (451 words)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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 in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylblisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosfA (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S 1S).It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confuimed by history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor.
The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic inpairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components, are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEXW Reconstruction System with the VERTEX"' rod connector. Refer to the VERTEX m Reconstruction System Package Insert for a list of the VERTEXTM indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050981 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050981: 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/K050981
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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