510(k) · Cleared
ClearedModification to CD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 3, 2003 after an 82-day review. The FDA summary names its predicate without a number. 49 later devices descend from it.
- Decided
- Sep 3, 2003
- Review
- 82 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 2 citing it directly.
- This deviceK031833 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 45 of its ownK162379 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 2 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 2 generations on · 16 of its ownK163375 INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK181139 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
- Descendant · 3 generations on · 8 of its ownK180851 VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016 · cites it directly45descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 2 generations on17descendants
- K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2017 · 2 generations on16descendants
- K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018 · 2 generations on8descendants
- K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031833 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K162379 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +2 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +2 | K163375 | INFINITY™ OCT System | Medtronic Sofamor Danek USA, Inc. | 2017 | 5 |
| +2 | K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 | — |
| +3 | K180851 | VERTEX™ Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 14 | 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.
Planning a device in MNI? 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? (1)
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 |
|---|---|---|---|
| * | — | CD HORIZON Spinal System Named without a submission number |
What descends from it? (49)
See all 492 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K162379 (Medtronic Sofamor Danek USA, Inc., 2016) has gone furthest, with 45 descendants of its own.
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 HORIZONB system is intended for the following indications: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZONB Spinal System is indicated for one or more of the following: ( 1 ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, ( 5 ) kyphosis, ( 6 ) spinal tumor, and/or (7) failed previous fusion…
Read the full statement (681 words)
The CD HORIZONB system is intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZONB Spinal System is indicated for one or more of the following: ( 1 ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, ( 5 ) kyphosis, ( 6 ) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
I n addition, when used as a pedicle screw fixation system, the CD HORIZON@ Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4)of the fifth lumbar-first sacral (LS-SI) vertebral joint; (b) wlio are receiving fusions using autogenous bone graft only; ( 3 ) wlio are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4)who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, iion-pedicle screw fixation system, the CD HORIZON@ Spinal System is 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 ) spondylolisthesis, (4)spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), ( 5 ) fracture, ( 6 ) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
SEXTANT Instrumentation
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON@ Cannulated M8 Multi-Axial Screw Components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON@ Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) 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); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON@ Cannulated M8 Multi-Axial Screw components are intended for: ( 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) spondylolisthesis, (4)spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
CD HOFUZONB ECLIPSEB
The CD HORIZON@ ECLIPSE@ components are intended for the following indications:
When used as an anterolateral thoracicllumbar system, the CD HORIZON@ Spinal System is 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 ) spondylolisthesis, (4)spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), ( 5 ) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
CD HORIZON@ Spinal System connected to VERTEXTMReconstruction System
In order to achieve additional levels of fixation, the CD HORIZON@ Spinal System rods may be connected to the VERTEXTMReconstruction System with the ERTEXTM rod connector. When connecting to the VERTEXTMReconstruction System in the cervical spine, components are intended for the following indications:
When intended to promote fusion of the cervical spine and the thoracic spine, (C 1 -T3), the VERTEXTMReconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C 1-T3) spine.
Multi-axial ScrewdLateral Connectors
The use of VERTEXTMmulti-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.
Titanium ATLASTMCable and the CD HORIZON@ Spinal System may be used with the VERTEXTMReconstruction System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031833: Modification to 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/K031833
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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