510(k) · Cleared
ClearedTIGR Matrix Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novus Scientific AB · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Jul 27, 2017 as substantially equivalent to K092224 (Novus Scientific Pte, Ltd., 2010) after a 272-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Jul 27, 2017
- Review
- 272 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851086 (1985). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK851086 Vicryl (Polyglactin 910/Mersilene Compoisite MeshETHICON, Inc. · 1985
- 1 generation backK092224 Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 2010 · Recalled
- This deviceK163005 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851086 | Vicryl (Polyglactin 910/Mersilene Compoisite Mesh | ETHICON, Inc. | 1985 | — |
| −1 | K092224 | Tigr Surgical Mesh , Model WK-6 | Novus Scientific Pte, Ltd. | 2010 | 1 |
| 0 (this device) | 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 |
|---|---|---|
| 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 OWT? 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 OWT device
- #1 K261543 Phasix ST Parastomal Hernia Meshscore 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K092224 | Tigr Surgical Mesh , Model WK-6Summary page 4…ric Classification Product Code: OWT Regulatory number: §878.3300 Predicate Device Name TIGR® Matrix Surgical Mesh (K092224) Device Description TIGR® Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181094 | Polydioxanone Surgical Scaffold | 2018 | 1 |
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 32 years and passes through 3 companies; a new generation was cleared every 24.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K181094 (Lntegra Lifesciences, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K092224.
How does its category compare?
All OWT devicesOWT Mesh, Surgical, Absorbable, Abdominal Hernia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OWT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWT
Too few OWT 510(k)s in any year since 2007 to give a median.
Recalls per year · OWT
No recall names OWT since 2007.
Adverse event reports per year · OWT
82in 2025
MAUDE reports naming product code OWT, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 1 | — | 0 | 31 |
| 2019 | 2 | — | 0 | 61 |
| 2020 | 1 | — | 0 | 45 |
| 2021 | 0 | — | 0 | 58 |
| 2022 | 0 | — | 0 | 104 |
| 2023 | 0 | — | 0 | 76 |
| 2024 | 1 | — | 0 | 65 |
| 2025 | 1 | — | 0 | 82 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163005: TIGR Matrix 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/K163005
Report an extraction error
Are you the manufacturer?
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