510(k) · Cleared
ClearedEndoform Plastics and Reconstructive Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aroa Biosurgery (Formerly Mesynthes Limited) · FTM Mesh, Surgical
Cleared on Dec 20, 2016 as substantially equivalent to K034039 (Cook Biotech, Inc., 2004) and 1 other predicate after a 109-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Dec 20, 2016
- Review
- 109 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921895 (1992). 21 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 2 generations backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- 1 generation backK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
- This deviceK162461 Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −2 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| −1 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | — |
| 0 (this device) | K162461 | Endoform Plastics and Reconstructive Matrix | Aroa Biosurgery (Formerly Mesynthes Limited) | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K034039 | Sis Plastic Surgery MatrixSummary page 4…Surgical Mesh Product Code: FTM 3. PREDICATE / REFERENCE DEVICES Predicate Device: • SIS Plastic Surgery Matrix (Cook Biotech) (K034039) • Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221) Reference Devices:… | 2004 |
| * | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugSummary page 4…cate Device: • SIS Plastic Surgery Matrix (Cook Biotech) (K034039) • Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug (K161221) Reference Devices: • Endoform® Reconstructive Template (Aroa Biosurgery) (K130547/K156366) 4. DEVICE DESCRIPTION… | 2016 |
| † | K130547 | Endoform Reconstructive Template | 2013 |
| † | K156366 | Endoform® Reconstructive Template |
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 24 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 21 ancestors has a recall.
- 11 other devices also cite its predicate K034039.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162461: Endoform Plastics and Reconstructive Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162461
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