510(k) · Cleared
ClearedModified Moss Miami 4.35MM Diameter Polyaxial Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuyacromed · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on May 16, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 712 devices in its family, counting itself, has a Class I recall. 711 later devices descend from it.
- Decided
- May 16, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
711 later devices descend from it, 14 citing it directly. 1 of the 712 devices in this family, counting this one, has a Class I recall.
- This deviceK011182 Modified Moss Miami 4.35MM Diameter Polyaxial ScrewsDepuyacromed · 2001
- Descendant · cites it directly · 539 of its ownK071495 Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007
- Descendant · cites it directly · 538 of its ownK073364 Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- Descendant · 2 generations on · 462 of its ownK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · cites it directly · 410 of its ownK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
Showing 5 of 711 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 711 · See all- K071495Expedium 4.5MM Spine SystemDepuy Spine, A Johnson & Johnson Company · 2007 · cites it directly539descendants
- K073364Expedium 4.5MM Spine SystemDepuy Spine, Inc. · 2008 · cites it directly538descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 2 generations on518descendants
- K090230Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on462descendants
- K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003 · cites it directly410descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011182 | Modified Moss Miami 4.35MM Diameter Polyaxial Screws | Depuyacromed | 2001 | — |
| +1 | K071495 | Expedium 4.5MM Spine System | Depuy Spine, A Johnson & Johnson Company | 2007 | — |
| +1 | K073364 | Expedium 4.5MM Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| +2 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +1 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 8 | 0 |
| 2008 | 17 | 0 |
| 2009 | 14 | 0 |
| 2010 | 13 | 0 |
| 2011 | 11 | 0 |
| 2012 | 33 | 0 |
| 2013 | 38 | 0 |
| 2014 | 31 | 0 |
| 2015 | 40 | 0 |
| 2016 | 33 | 0 |
| 2017 | 48 | 0 |
| 2018 | 47 | 0 |
| 2019 | 41 | 0 |
| 2020 | 39 | 0 |
| 2021 | 30 | 1 |
| 2022 | 38 | 0 |
| 2023 | 63 | 0 |
| 2024 | 60 | 0 |
| 2025 | 53 | 0 |
| 2026 | 48 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (711)
See all 71114 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071495 | Expedium 4.5MM Spine System | 2007 | 539 |
| K073364 | Expedium 4.5MM Spine System | 2008 | 538 |
| K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | 2003 | 410 |
| K082195 | Modifications to Expedium Spine System | 2008 | 269 |
| K070387 | Expedium Spine System | 2007 | 248 |
| K073562 | Modification to Viper Spine System | 2008 | 213 |
| K111571 | Viper Systems | 2011 | 203 |
| K102701 | Viper Spine System | 2010 | 184 |
| K120291 | OP Spine System | 2012 | 138 |
| K051704 | Mykres Spinal System | 2006 | 6 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K071495 (Depuy Spine, A Johnson & Johnson Company, 2007) has gone furthest, with 539 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K011182 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011182: Modified Moss Miami 4.35MM Diameter Polyaxial Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011182
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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