510(k) · Cleared
ClearedPolydioxanone Surgical Scaffold
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lntegra Lifesciences · FTL Mesh, Surgical, Polymeric
Cleared on Aug 2, 2018 as substantially equivalent to K163005 (Novus Scientific AB, 2017) and 1 other predicate after a 99-day review. Its family tree reaches back 3 generations to 1985. 1 later device descends from it.
- Decided
- Aug 2, 2018
- Review
- 99 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K851086 (1985). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK851086 Vicryl (Polyglactin 910/Mersilene Compoisite MeshETHICON, Inc. · 1985
- 2 generations backK092224 Tigr Surgical Mesh , Model WK-6Novus Scientific Pte, Ltd. · 2010 · Recalled
- 1 generation backK163005 TIGR Matrix Surgical MeshNovus Scientific AB · 2017
- This deviceK181094 Polydioxanone Surgical ScaffoldLntegra Lifesciences · 2018
- Descendant · cites it directly · 0 of its ownK260474 Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851086 | Vicryl (Polyglactin 910/Mersilene Compoisite Mesh | ETHICON, Inc. | 1985 | — |
| −2 | K092224 | Tigr Surgical Mesh , Model WK-6 | Novus Scientific Pte, Ltd. | 2010 | 1 |
| −1 | K163005 | TIGR Matrix Surgical Mesh | Novus Scientific AB | 2017 | — |
| 0 (this device) | K181094 | Polydioxanone Surgical Scaffold | Lntegra Lifesciences | 2018 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K163005 | TIGR Matrix Surgical MeshSummary page 4…: Mesh, Surgical, Polymeric Regulatory Class: Class II Product Code: OWT Predicate Device Novus Scientific AB, TIGR® Matrix Surgical Mesh, K163005, K092224 Intended Use / Indications for Use Polydioxanone Surgical Scaffold™ is intended for use in reinforcement of s… | 2017 |
| * | K092224 | Tigr Surgical Mesh , Model WK-6Summary page 4…, Surgical, Polymeric Regulatory Class: Class II Product Code: OWT Predicate Device Novus Scientific AB, TIGR® Matrix Surgical Mesh, K163005, K092224 Intended Use / Indications for Use Polydioxanone Surgical Scaffold™ is intended for use in reinforcement of soft tissu… | 2010 |
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 |
|---|---|---|---|
| K260474 | Liora Monofilament Scaffold | 2026 | 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 33 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K260474 (TELA Bio, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Polydioxanone Surgical Scaffold 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/K181094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181094: Polydioxanone Surgical Scaffold.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181094
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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