510(k) · Cleared
ClearedEndoform Reconstructive Template - PLGA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aroa Biosurgery, Ltd. · FTM Mesh, Surgical
Cleared on Jun 3, 2025 as substantially equivalent to K153633 (Aroa Biosurgery Limited (Formerly Mesynthes Limited), 2016) after a 95-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jun 3, 2025
- Review
- 95 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921895 (1992). 26 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 4 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 3 generations backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- 2 generations backK130547 Endoform Reconstructive TemplateMesynthe, Ltd. · 2013
- 1 generation backK153633 Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) · 2016 · Recalled
- This deviceK250598 Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −4 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| −3 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| −2 | K130547 | Endoform Reconstructive Template | Mesynthe, Ltd. | 2013 | — |
| −1 | K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016 | 21 |
| 0 (this device) | K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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 |
|---|---|---|---|
| * | K153633 | Endoform Reconstructive TemplateSummary page 5…Mesh, Surgical Classification name FTM Product code Endoform™ Reconstructive Template (K153633) Predicate device OviTex PRS (Long Term Resorbable) (K214070) Reference device D… | 2016 |
| † | K214070 | OviTex PRS (Long Term Resorbable) | 2023 |
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 33 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 26 ancestors have a recall of any class.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250598 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250598: Endoform Reconstructive Template - PLGA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250598
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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