510(k) · Cleared
ClearedModification to Vertex Reconstruction 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 Jan 5, 2006 as substantially equivalent to K042789 (Medtronic Sofamor Danek, 2004) after a 21-day review. Its family tree reaches back 2 generations to 2001. 262 later devices descend from it.
- Decided
- Jan 5, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003780 (2001). 262 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK042789 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004
- This deviceK053483 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 233 of its ownK090714 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
- Descendant · cites it directly · 150 of its ownK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 128 of its ownK111510 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · 3 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 262 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 262 · See all- K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009 · cites it directly233descendants
- K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · cites it directly150descendants
- K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 2 generations on128descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · 3 generations on127descendants
- K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on106descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003780 | Vertex Reconstruction System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K042789 | Vertex Reconstruction System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K053483 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek | 2009 | — |
| +1 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K111510 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +3 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| +2 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 15 | 0 |
| 2014 | 17 | 0 |
| 2015 | 18 | 0 |
| 2016 | 14 | 0 |
| 2017 | 18 | 0 |
| 2018 | 17 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 26 | 0 |
| 2024 | 20 | 0 |
| 2025 | 18 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K042789 | Vertex Reconstruction SystemSummary page 2…d demonstrating that the subject VERTEXTM Reconstruction System components are substantially equivalent to VERTEX® Reconstruction System components previously cleared in K042789 (SE 12/21/04). The labeling is identical to that cleared in K052734 (SE 10/21/05). DEPARTMENT OF HEALTH & HUM… | 2004 |
| † | K052734 | Modification to: Vertex Reconstruction System | 2005 |
What descends from it? (262)
See all 2623 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090714 (Medtronic Sofamor Danek, 2009) has gone furthest, with 233 descendants of its own.
- 9 other devices also cite its predicate K042789.
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?
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® 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 and/or tumors. Occipitocervical Plate/Rod/Occipital Screws/Hooks The…
Read the full statement (226 words)
When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® 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 and/or tumors.
Occipitocervical Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous along with 4.0mm and 4.5mm cortical), and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.
The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
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 (C1-T3) spine.
Multi-axial Screws/Connectors
The use of multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.
Titanium ATLAS® Cable System used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053483: Modification to Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053483
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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