510(k) · Cleared
ClearedModification to TSRH Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on May 4, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- May 4, 2001
- Review
- 25 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly.
- This deviceK011067 Modification to TSRH Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK072429 Modification to TSRH Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 8 of its ownK081978 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009
- Descendant · 2 generations on · 7 of its ownK101112 Reliance Spinal Screw SystemReliance Medical Systems · 2010
- Descendant · 3 generations on · 5 of its ownK123521 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013
- Descendant · 2 generations on · 5 of its ownK110896 Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072429Modification to TSRH Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly10descendants
- K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2009 · 2 generations on8descendants
- K101112Reliance Spinal Screw SystemReliance Medical Systems · 2010 · 2 generations on7descendants
- K123521Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2013 · 3 generations on5descendants
- K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011067 | Modification to TSRH Spinal System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| +1 | K072429 | Modification to TSRH Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K081978 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2009 | — |
| +2 | K101112 | Reliance Spinal Screw System | Reliance Medical Systems | 2010 | — |
| +3 | K123521 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2013 | — |
| +2 | K110896 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K072429 | Modification to TSRH Spinal System | 2007 | 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, K072429 (Medtronic Sofamor Danek, 2007) 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 | — |
https://510kreport.com/device/K011067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011067: Modification to TSRH Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011067
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026