510(k) · Cleared
ClearedDepuy Motech Moss Miami Spinal System - Pedicle Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Motech · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 22, 1995 after a 136-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 850 devices in its family, counting itself, has a Class I recall. 849 later devices descend from it.
- Decided
- Jun 22, 1995
- Review
- 136 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
849 later devices descend from it, 16 citing it directly. 1 of the 850 devices in this family, counting this one, has a Class I recall.
- This deviceK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- Descendant · cites it directly · 742 of its ownK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- Descendant · 2 generations on · 735 of its ownK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- Descendant · 3 generations on · 734 of its ownK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- Descendant · 4 generations on · 710 of its ownK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- Descendant · 5 generations on · 518 of its ownK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
Showing 5 of 849 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 849 · See all- K050461Xia 4.5 Spinal SystemStryker Spine · 2005 · cites it directly742descendants
- K052761Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005 · 2 generations on735descendants
- K060361Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · 3 generations on734descendants
- K060979Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006 · 4 generations on710descendants
- K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008 · 5 generations on518descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| +1 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| +2 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| +3 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| +4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| +5 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 8 | 0 |
| 2007 | 16 | 0 |
| 2008 | 14 | 0 |
| 2009 | 18 | 0 |
| 2010 | 16 | 0 |
| 2011 | 16 | 0 |
| 2012 | 38 | 0 |
| 2013 | 40 | 0 |
| 2014 | 39 | 0 |
| 2015 | 46 | 0 |
| 2016 | 45 | 0 |
| 2017 | 58 | 0 |
| 2018 | 59 | 0 |
| 2019 | 47 | 0 |
| 2020 | 49 | 0 |
| 2021 | 36 | 1 |
| 2022 | 45 | 0 |
| 2023 | 71 | 0 |
| 2024 | 66 | 0 |
| 2025 | 60 | 0 |
| 2026 | 55 | 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? (849)
See all 84916 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050461 | Xia 4.5 Spinal System | 2005 | 742 |
| K071373 | Stryker Spine Xia Iii Spinal System | 2007 | 430 |
| K982511 | Depuy Motech Moss Miami Spinal Systems | 1998 | 413 |
| K083393 | Xia 3 Spinal System | 2009 | 292 |
| K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | 2009 | 169 |
| K060748 | Modification to Xia 4.5 Spinal System | 2006 | 134 |
| K092605 | Xia 4.5 Spinal System | 2009 | 98 |
| K101144 | Modification to:Radius Spinal System | 2010 | 90 |
| K120696 | Tiger Spine System | 2012 | 41 |
| K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | 2015 | 31 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K050461 (Stryker Spine, 2005) has gone furthest, with 742 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/K950697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950697: Depuy Motech Moss Miami Spinal System - Pedicle Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950697
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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