510(k) · Cleared
Recalled · 2006MSD Silo 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 Nov 4, 2004 as substantially equivalent to K041030 (Medtronic Sofamor Danek, 2004) after an 80-day review. Its family tree reaches back 2 generations to 1999. 1 of the 670 devices in its family, counting itself, has a Class I recall. 666 later devices descend from it. It has been recalled once.
- Decided
- Nov 4, 2004
- Review
- 80 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K981676 (1999). 3 ancestors in all. 666 later devices descend from it, 2 citing it directly. 1 of the 670 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 1 generation backK041030 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- This deviceK042210 MSD Silo Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 665 of its ownK052144 TSRH Spinal SystemMedtronic Sofamor Danek · 2005 · Recalled
- Descendant · 2 generations on · 663 of its ownK090390 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 3 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 4 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
Showing 5 of 666 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 666 · See all- K052144TSRH Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly665descendants
- K090390CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · 2 generations on663descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 3 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 4 generations on598descendants
- K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 4 generations on597descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −1 | K041030 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K042210 | MSD Silo Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K052144 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | 1 |
| +2 | K090390 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +4 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +4 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 14 | 0 |
| 2013 | 24 | 0 |
| 2014 | 34 | 0 |
| 2015 | 37 | 0 |
| 2016 | 39 | 0 |
| 2017 | 44 | 0 |
| 2018 | 48 | 0 |
| 2019 | 38 | 0 |
| 2020 | 46 | 0 |
| 2021 | 45 | 1 |
| 2022 | 48 | 0 |
| 2023 | 67 | 0 |
| 2024 | 60 | 0 |
| 2025 | 57 | 0 |
| 2026 | 54 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K041030 | Modification to CD Horizon Spinal SystemSummary page 2…test reports, was provided which demonstrated the MSD SiloTM Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in 1K041030. 0 0 00 6: ft ~~DEPARTMENT… | 2004 |
What descends from it? (666)
See all 6662 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2006 | Not classified | Z-0411-2007 | Other | Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 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 5.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K052144 (Medtronic Sofamor Danek, 2005) has gone furthest, with 665 descendants of its own.
- 4 other devices also cite its predicate K041030.
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 MSD SiLoTM System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when…
Read the full statement (124 words)
The MSD SiLoTM System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the MSD SiLoTM components are 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042210 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042210: MSD Silo 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/K042210
Report an extraction error
Are you the manufacturer?
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