510(k) · Cleared
ClearedEndoform Reconstructive Template
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesynthe, Ltd. · FTM Mesh, Surgical
Cleared on May 31, 2013 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 2 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1992. 5 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 88 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K921895 (1992). 24 ancestors in all, the oldest K830889 (1983). 5 later devices descend from it, 2 citing it directly.
- 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 backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 2 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 1 generation backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- This deviceK130547 Endoform Reconstructive TemplateMesynthe, Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK141053 Ovine Tissue Matrix (Otm)TELA Bio, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK153632 Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) · 2016
- Descendant · cites it directly · 1 of its ownK153633 Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK250598 Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK181935 Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K141053Ovine Tissue Matrix (Otm)TELA Bio, Inc. · 2014 · cites it directly2descendants
- K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) · 2016 · 2 generations on1descendant
- K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) · 2016 · cites it directly1descendant
- K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025 · 2 generations on0descendants
- K181935Endoform Reconstructive Template - Non AbsorbableAroa Biosurgery, Ltd. · 2018 · 3 generations on0descendants
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 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −2 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| −1 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| 0 (this device) | K130547 | Endoform Reconstructive Template | Mesynthe, Ltd. | 2013 | — |
| +1 | K141053 | Ovine Tissue Matrix (Otm) | TELA Bio, Inc. | 2014 | — |
| +2 | K153632 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016 | — |
| +1 | K153633 | Endoform Reconstructive Template | Aroa Biosurgery Limited (Formerly Mesynthes Limited) | 2016 | 21 |
| +2 | K250598 | Endoform Reconstructive Template - PLGA | Aroa Biosurgery, Ltd. | 2025 | — |
| +3 | K181935 | Endoform Reconstructive Template - Non Absorbable | Aroa Biosurgery, Ltd. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 1…e Common/Usual Name: Surgical Mesh Classification Name: FTL 3. Predicate Devices " SurgiSIS& 1- and 4-ply (Cook Biotech) (K980431) * 515 Hernia Repair Device, SurgiSIS® Gold Hernia Repair Graft, 8-ply (Cook Biotech) (K062697) *… | 1998 |
| * | K062697 | Sis Hernia Repair Device, Surgisis Gold Hernia Repair GraftSummary page 1…" SurgiSIS& 1- and 4-ply (Cook Biotech) (K980431) * 515 Hernia Repair Device, SurgiSIS® Gold Hernia Repair Graft, 8-ply (Cook Biotech) (K062697) * Strattice®)LTM Surgical Mesh (LifeCell).(K070560) 4. Device Description The Mesynthes EndoformnTM Reconstructi… | 2006 |
| * | K070560 | LRTM Surgical MeshSummary page 1…* 515 Hernia Repair Device, SurgiSIS® Gold Hernia Repair Graft, 8-ply (Cook Biotech) (K062697) * Strattice®)LTM Surgical Mesh (LifeCell).(K070560) 4. Device Description The Mesynthes EndoformnTM Reconstructive Template (ERT) is a surgical mesh comprising either a… | 2007 |
| † | K092096 | Endoform Dermal Template | 2010 |
| † | K101546 | Endoform Dental Template | 2010 |
| † | K102592 | Sutrazorb | 2011 |
| † | K830889 | Dexon 'S' Polyglycolic Acid Mesh | 1983 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 24 ancestors have a recall of any class.
- Of its descendants, K141053 (TELA Bio, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 28 other devices also cite its predicate K980431.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 is intended for use as a surgical mesh to
reinforce and/or repair soft tissue where weakness exists. Indications for use include,
but are not limited to the following procedures; hernioplasty and repair of body wall
defects. The device allows reinforcement or bridging of a deficit to obtain the desired
surgical outcome. Endoform Reconstructive Template is intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130547: Endoform Reconstructive Template.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130547
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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