510(k) · Cleared
ClearedTilghman Titanium Mesh Skeletal Orbit Liner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ti-Mesh, Inc. · FTM Mesh, Surgical
Cleared on Jan 12, 1993 after a 242-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 85 later devices descend from it.
- Decided
- Jan 12, 1993
- Review
- 242 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 0
85 later devices descend from it, 1 citing it directly.
- This deviceK922308 Tilghman Titanium Mesh Skeletal Orbit LinerTi-Mesh, Inc. · 1993
- 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 85 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 85 · 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) | K922308 | Tilghman Titanium Mesh Skeletal Orbit Liner | Ti-Mesh, Inc. | 1993 | — |
| +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 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 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 FTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (85)
See all 851 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972913 | Macropore Protective Sheet (Protego System) | 1998 | 84 |
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 FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K922308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922308: Tilghman Titanium Mesh Skeletal Orbit Liner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922308
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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