510(k) · Cleared
ClearedVertefix Pedicle Screw Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elite Surgical Supplies (Pty), Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Aug 30, 2007 as substantially equivalent to K051971 (U&I Corp., 2005) after a 288-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Aug 30, 2007
- Review
- 288 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K051971 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK051971 Optima Spinal SystemU&I Corp. · 2005
- This deviceK063453 Vertefix Pedicle Screw Spinal SystemElite Surgical Supplies (Pty), Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK080075 Modification to: Vertefix Pedicle Screw Spinal SystemElite Surgical Supplies (Pty), Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080075Modification to: Vertefix Pedicle Screw Spinal SystemElite Surgical Supplies (Pty), Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051971 | Optima Spinal System | U&I Corp. | 2005 | — |
| 0 (this device) | K063453 | Vertefix Pedicle Screw Spinal System | Elite Surgical Supplies (Pty), Ltd. | 2007 | — |
| +1 | K080075 | Modification to: Vertefix Pedicle Screw Spinal System | Elite Surgical Supplies (Pty), Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051971 | Optima Spinal System | 2005 |
| Kept off the family tree | K042655 | FDA’s K042655 is Inspiration Elite Nebulizer Compressor, with Nebulizer, Model HS456 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| Kept off the family tree | K003190 | FDA’s K003190 is EN Bloc Biopsy System Our reading of the summary gave K003190, FDA’s number for EN Bloc Biopsy System (Neothermia Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “XIA Spine System Hooks”. Kept off the family tree. | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080075 | Modification to: Vertefix Pedicle Screw Spinal System | 2008 | 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?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Vertefix® Pedicle Screw System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients receiving fusion by autogenous bone graft in the thoracolumbar spine, for the following indications:
Spondylolisthesis;
Trauma (e.g. fracture or dislocation);
Spinal stenosis;
Deformities or curvatures (scoliosis, kyphosis and lordosis)
Tumor;
Pseudoarthrosis; and
Failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063453: Vertefix Pedicle Screw 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/K063453
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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