510(k) · Cleared
ClearedMesosfol Surgical Film
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · FTM Mesh, Surgical
Cleared on Jun 20, 2007 as substantially equivalent to K031955 (Macropore Biosurgery, Inc., 2003) and 1 other predicate after a 294-day review. Its family tree reaches back 3 generations to 2001. 21 later devices descend from it.
- Decided
- Jun 20, 2007
- Review
- 294 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002699 (2001). 5 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002699 Parietex Composite (Pco) MeshMedical Device Consultants, Inc. · 2001
- 2 generations backK031955 Macropore Surgi-Wrap Mast Bioresorbable SheetMacropore Biosurgery, Inc. · 2003
- 1 generation backK042811 Vivosorb Sheet, Model FS01Polyganics B.V., · 2004
- This deviceK062558 Mesosfol Surgical FilmBiomet Manufacturing Corp · 2007
- Descendant · cites it directly · 18 of its ownK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- Descendant · 2 generations on · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- Descendant · 3 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009 · cites it directly18descendants
- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · 2 generations on10descendants
- K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · 2 generations on5descendants
- K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd. · 2017 · 3 generations on4descendants
- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002699 | Parietex Composite (Pco) Mesh | Medical Device Consultants, Inc. | 2001 | — |
| −2 | K031955 | Macropore Surgi-Wrap Mast Bioresorbable Sheet | Macropore Biosurgery, Inc. | 2003 | — |
| −1 | K042811 | Vivosorb Sheet, Model FS01 | Polyganics B.V., | 2004 | — |
| 0 (this device) | K062558 | Mesosfol Surgical Film | Biomet Manufacturing Corp | 2007 | — |
| +1 | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| +2 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +2 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| +3 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| +3 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K031955 | Macropore Surgi-Wrap Mast Bioresorbable SheetSummary page 1…egally Marketed Devices To Which Substantial Equivalence Is Claimed: Mesofol® Surgical Sheet is substantially equivalent to MacroPore Surgi-Wrap MAST Bioresorbable Sheet K031955 and Polyganics VivoSorb® Sheet K042811. Device Description: Mesofol® Surgical Sheet is an implantable, resorbable, polymeric sur… | 2003 |
| * | K042811 | Vivosorb Sheet, Model FS01Summary page 1…ntial Equivalence Is Claimed: Mesofol® Surgical Sheet is substantially equivalent to MacroPore Surgi-Wrap MAST Bioresorbable Sheet K031955 and Polyganics VivoSorb® Sheet K042811. Device Description: Mesofol® Surgical Sheet is an implantable, resorbable, polymeric surgical sheet manufactured by ITV Denkend… | 2004 |
What descends from it? (21)
See all 212 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 6 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K090160 (Polymedics Innovations, GmbH, 2009) has gone furthest, with 18 descendants of its own.
- 8 other devices also cite its predicate K031955.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Mesofol® Surgical Sheet is indicated when temporary wound support is required to
reinforce soft tissues where weakness exists, or in conjunction with hernia repair or
other fascial defects that require the addition of a reinforcing or bridging material to
obtain the desired surgical result. The resorbable protective sheet minimizes tissue
attachment to the device in case of direct contact with the viscera.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062558 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062558: Mesosfol Surgical Film.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062558
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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