510(k) · Cleared
ClearedMotech Titanium Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biedermann Motech GmbH · EZX Mesh, Surgical, Metal
Cleared on Mar 20, 1990 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 137 later devices descend from it.
- Decided
- Mar 20, 1990
- Review
- 68 days
- Class
- Class II
- Product code
- EZX
- Recalls
- None
- Predicates
- 0
137 later devices descend from it, 5 citing it directly.
- This deviceK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
- Descendant · cites it directly · 84 of its ownK972913 Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
- Descendant · 2 generations on · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- Descendant · 2 generations on · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- Descendant · 3 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- Descendant · 4 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Showing 5 of 137 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 137 · See all- K972913Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998 · cites it directly84descendants
- K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · 2 generations on79descendants
- K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · 2 generations on73descendants
- K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 3 generations on65descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900138 | Motech Titanium Surgical Mesh | Biedermann Motech GmbH | 1990 | — |
| +1 | K972913 | Macropore Protective Sheet (Protego System) | Pacific Materials and Interfaces | 1998 | — |
| +2 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| +2 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| +3 | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| +4 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 8 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 12 | 0 |
| 2024 | 14 | 0 |
| 2025 | 16 | 0 |
| 2026 | 14 | 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 EZX? 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? (137)
See all 1375 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K972913 (Pacific Materials and Interfaces, 1998) has gone furthest, with 84 descendants of its own.
How does its category compare?
All EZX devicesEZX Mesh, Surgical, Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · EZX
Too few EZX 510(k)s in any year since 2007 to give a median.
Recalls per year · EZX
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZX
1in 2025
MAUDE reports naming product code EZX, 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 | 0 | — | 0 | 4 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 0 | — | 0 | 35 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K900138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K900138: Motech Titanium Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900138
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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