510(k) · Cleared
ClearedTrulene Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sutures India Pvt., Ltd. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 26, 2006 as substantially equivalent to K905655 (United States Surgical, A Division of Tyco Healthc, 1990) and 1 other predicate after a 203-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Jul 26, 2006
- Review
- 203 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945377 (1994). 9 ancestors in all, the oldest K905655 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK945377 Trelex Natural (R) MeshMeadox Medicals, Div. Boston Scientific Corp. · 1994
- 2 generations backK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
- 1 generation backK041632 Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · Recalled
- This deviceK060018 Trulene MeshSutures India Pvt., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945377 | Trelex Natural (R) Mesh | Meadox Medicals, Div. Boston Scientific Corp. | 1994 | — |
| −2 | K020110 | Modification to Trelex Mesh Surgical Mesh | Boston Scientific | 2002 | — |
| −1 | K041632 | Minimesh Polypropylene Mesh | Mpathy Medical Devices, Ltd. | 2004 | 1 |
| 0 (this device) | K060018 | Trulene Mesh | Sutures India Pvt., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K905655 | Nonabsorbable Polypropylene Surgical MeshSummary page 1…l Mesh Classification Name :Mesh Surgical Polymeric D. PREDICATE DEVICES: (1) Device Name: Nonabsorbable Polypropylene Surgical Mesh 510(k) Number: K 905655 Manufacturer: United States Surgicals, A Division of Tyco Health, 150, Glover Aye, Norwalk CT 06856 (2) Device Name… | 1990 |
| * | K041632 | Minimesh Polypropylene MeshSummary page 1…, 150, Glover Aye, Norwalk CT 06856 (2) Device Name (Proprietary): Minimesh Generic / Common Name: Polymeric Surgical Mesh 510 (k) Number: K 041632 Manufacturer: Mpathy Medical Devices Ltd, 150, Aran Hill road, Fairfield, CT 06824 1712 E. REGULATION NUMBER: 878.… | 2004 |
| * | — | Ethicon Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K905655.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR AND OTHER FASCIAL DEFICIENCIES THAT REQUIRE THE ADDITION OF A REINFORCING OR BRIDGING MATERIAL TO OBTAIN THE DESIRED SURGICAL RESULT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060018 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060018: Trulene Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060018
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026