510(k) · Cleared
ClearedMoss Miami 5.5MM Titanium Pin Nut
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 Apr 12, 2001 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 273 devices in its family, counting itself, has a Class I recall. 272 later devices descend from it.
- Decided
- Apr 12, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
272 later devices descend from it, 3 citing it directly. 1 of the 273 devices in this family, counting this one, has a Class I recall.
- This deviceK010742 Moss Miami 5.5MM Titanium Pin NutDepuyacromed · 2001
- Descendant · cites it directly · 265 of its ownK023804 Moss Miami Spinal System Pin NutDepuyacromed · 2003
- Descendant · 2 generations on · 263 of its ownK092473 Expedium Spine SystemDepuy Spine, Inc. · 2009
- Descendant · 3 generations on · 260 of its ownK101070 Expedium Spine SystemMedos International SARL · 2010 · Recalled
- Descendant · 4 generations on · 225 of its ownK122226 Revere Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · 5 generations on · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
Showing 5 of 272 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 272 · See all- K023804Moss Miami Spinal System Pin NutDepuyacromed · 2003 · cites it directly265descendants
- K092473Expedium Spine SystemDepuy Spine, Inc. · 2009 · 2 generations on263descendants
- K101070Expedium Spine SystemMedos International SARL · 2010 · 3 generations on260descendants
- K122226Revere Stabilization SystemGlobus Medical, Inc. · 2012 · 4 generations on225descendants
- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · 5 generations on172descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010742 | Moss Miami 5.5MM Titanium Pin Nut | Depuyacromed | 2001 | — |
| +1 | K023804 | Moss Miami Spinal System Pin Nut | Depuyacromed | 2003 | — |
| +2 | K092473 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| +3 | K101070 | Expedium Spine System | Medos International SARL | 2010 | 1 |
| +4 | K122226 | Revere Stabilization System | Globus Medical, Inc. | 2012 | — |
| +5 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 14 | 0 |
| 2019 | 15 | 0 |
| 2020 | 19 | 0 |
| 2021 | 15 | 1 |
| 2022 | 24 | 0 |
| 2023 | 35 | 0 |
| 2024 | 41 | 0 |
| 2025 | 37 | 0 |
| 2026 | 32 | 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? (272)
See all 2723 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)
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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K023804 (Depuyacromed, 2003) has gone furthest, with 265 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/K010742 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010742: Moss Miami 5.5MM Titanium Pin Nut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010742
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026