510(k) · Cleared
ClearedTransorb™ Self-Gripping Resorbable Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofradim Production · OWT Mesh, Surgical, Absorbable, Abdominal Hernia
Cleared on Feb 13, 2024 as substantially equivalent to K191749 (Novus Scientific AB, 2020) after a 90-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Feb 13, 2024
- Review
- 90 days
- Class
- Class II
- Product code
- OWT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K002699 (2001). 15 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 6 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 5 generations backK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- 4 generations backK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
- 3 generations backK142818 Phasix MeshC. R. Bard · 2015
- 2 generations backK161424 Phasix MeshC.R. Bard, Inc. · 2016
- 1 generation backK191749 TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB · 2020
- This deviceK233661 Transorb™ Self-Gripping Resorbable MeshSofradim Production · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −6 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −5 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| −4 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
| −3 | K142818 | Phasix Mesh | C. R. Bard | 2015 | — |
| −2 | K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016 | — |
| −1 | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K191749 | TIGR Matrix Surgical Mesh, TIGR Surgical MeshSummary page 4…Surgery Panel number and product code: OWT, FTL, OOD Regulation number: 21 CFR 878.3300 510(k) Number: K191749 Manufacturer: Novus Scientific AB, Virdings Alle 2, Uppsala, SE Se-754 50 Reference Device 1: Trade/Proprietary nam… | 2020 |
| † | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D… | 2022 |
| † | K161424 | Phasix Mesh | 2016 |
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 23 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- None of the 15 ancestors has a recall.
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. 2024, 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?
Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233661: Transorb™ Self-Gripping Resorbable Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233661
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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