510(k) · Cleared
ClearedTIGR Matrix Surgical Mesh, TIGR 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 Mar 26, 2020 as substantially equivalent to K161424 (C.R. Bard, Inc., 2016) after a 269-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Mar 26, 2020
- Review
- 269 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K002699 (2001). 14 ancestors in all, the oldest K810428 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 5 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 4 generations backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- 3 generations backK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- 2 generations backK142818 Phasix MeshC. R. Bard · 2015
- 1 generation backK161424 Phasix MeshC.R. Bard, Inc. · 2016
- This deviceK191749 TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020
- Descendant · cites it directly · 0 of its ownK233661 Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024
Most influential descendants
Showing 1 of 1 · See all- K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −5 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −4 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| −3 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| −2 | K142818 | Phasix Mesh | C. R. Bard | 2015 | — |
| −1 | K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016 | — |
| 0 (this device) | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020 | — |
| +1 | K233661 | Transorb™ Self-Gripping Resorbable Mesh | Sofradim Production | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K161424 | Phasix MeshSummary page 4…& Plastic Surgery Product Codes: OWT, OOD, FTL Regulation: 21 CFR, 878.3300 III. PREDICATE DEVICE Primary Predicate: CR. Bard, Inc. Phasix Mesh (K161424) Refence Predicate: Novus Scientific, AB TIGR® Matrix Surgical Mesh (K163005) IV. DEVICE DESCRIPTION Technologi… | 2016 |
| † | K163005 | TIGR Matrix Surgical Mesh | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | 2024 | 0 |
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 19 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K233661 (Sofradim Production, 2024) has gone furthest, with 0 descendants of its own.
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. 2020, 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?
The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191749: TIGR Matrix Surgical Mesh, TIGR 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/K191749
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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