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 Jun 27, 2003 after a 9-day review. The FDA summary names no predicate by number. 11 later devices descend from it.
- Decided
- Jun 27, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK031888 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 10 of its ownK153589 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · 2 generations on · 6 of its ownK161842 Overwatch Spine SystemAmendia, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 5 of its ownK191576 Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019
- Descendant · 4 generations on · 3 of its ownK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- Descendant · 5 generations on · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016 · cites it directly10descendants
- K161842Overwatch Spine SystemAmendia, Inc. · 2016 · 2 generations on6descendants
- K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019 · 3 generations on5descendants
- K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022 · 4 generations on3descendants
- K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031888 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K153589 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +2 | K161842 | Overwatch Spine System | Amendia, Inc. | 2016 | 1 |
| +3 | K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019 | — |
| +4 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| +5 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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?
The FDA summary names no predicate by number.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153589 | CD HORIZON Spinal System | 2016 | 10 |
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, K153589 (Medtronic Sofamor Danek USA, Inc., 2016) has gone furthest, with 10 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 HORIZON@ 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 HORIZON@ 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, andor (7) failed previous fusion…
Read the full statement (599 words)
The CD HORIZON@ 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 HORIZON@ 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, andor (7) failed previous fusion (pseudarthrosis).
In 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 (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who 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, non-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, andor lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion.
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.
(1.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON@ ECLIPSE@ components arc intended for the following indications:.
When used as an anterolateral thoracic/lumbar system, the CD HORIZONB 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.
In order to achieve additional levels of fixation, the CD HORIZONB Spinal System rods may be connected to the VERTEXT" Reconstruction System with the VERTEXTMrod 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 VERTEXT" Reconstruction 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 andor 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 Screws/Lateral Connectors
The use of VERTEXTMmulti-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in Tl-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.
Titanium ATLAST" Cable and the CD HOEUZONB Spinal System may be used with the VERTEXThI Reconstruction System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031888: 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/K031888
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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