510(k) · Cleared
Recalled · Class II · 2016Tigr Surgical Mesh , Model WK-6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novus Scientific Pte, Ltd. · FTL Mesh, Surgical, Polymeric
Cleared on Jan 25, 2010 as substantially equivalent to K001122 (ETHICON, Inc., 2000) and 2 other predicates after a 186-day review. Its family tree reaches back 1 generation to 1985. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 25, 2010
- Review
- 186 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K851086 (1985). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851086 Vicryl (Polyglactin 910/Mersilene Compoisite MeshETHICON, Inc. · 1985
- This deviceK092224 Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK163005 TIGR Matrix Surgical MeshNovus Scientific AB · 2017
- Descendant · cites it directly · 1 of its ownK181094 Polydioxanone Surgical ScaffoldLntegra Lifesciences · 2018
- Descendant · 2 generations on · 0 of its ownK260474 Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851086 | Vicryl (Polyglactin 910/Mersilene Compoisite Mesh | ETHICON, Inc. | 1985 | — |
| 0 (this device) | K092224 | Tigr Surgical Mesh , Model WK-6 | Novus Scientific Pte, Ltd. | 2010 | — |
| +1 | K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017 | — |
| +1 | K181094 | Polydioxanone Surgical Scaffold | Lntegra Lifesciences | 2018 | — |
| +2 | K260474 | Liora Monofilament Scaffold | TELA Bio, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K001122 | Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh | 2000 |
| * | K851086 | Vicryl (Polyglactin 910/Mersilene Compoisite MeshSummary page 1…mber: §878.3300 Predicate Device Names: Prolene Mesh (KOOI1 122) Mersilene Mesh (K85 1086) Ultrapro Mesh (K033337) Device Description: TIGR Matrix Surgical Mesh is knitted… | 1985 |
| * | K033337 | Ultrapro MeshSummary page 1…Prolene Mesh (KOOI1 122) Mersilene Mesh (K85 1086) Ultrapro Mesh (K033337) Device Description: TIGR Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different… | 2004 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2016 | Class II | Z-2603-2016 | Other | Novus Scientific is implementing additions to the product's instructions for use concerning certain inguinal hernia repairs. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
TIGR Matrix Surgical Mesh is indicated for use in reinforcement of soft tissue where weakness exists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092224 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092224: Tigr Surgical Mesh , Model WK-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092224
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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