510(k) · Cleared
Recalled · Class II · 2013Seriscaffold Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serica Technologies, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Nov 13, 2008 as substantially equivalent to K810428 (ETHICON, Inc., 1981) and 1 other predicate after a 268-day review. Its family tree reaches back 4 generations to 1992. 14 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 2008
- Review
- 268 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K921895 (1992). 14 ancestors in all, the oldest K810428 (1981). 14 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- This deviceK080442 Seriscaffold Surgical MeshSerica Technologies, Inc. · 2008
- Descendant · cites it directly · 7 of its ownK090288 Orthadapt PRPegasus Biologics, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK123128 Seri Surgical ScaffoldAllergan · 2013
- Descendant · 2 generations on · 5 of its ownK112786 Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K090288Orthadapt PRPegasus Biologics, Inc. · 2009 · cites it directly7descendants
- K123128Seri Surgical ScaffoldAllergan · 2013 · cites it directly5descendants
- K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc. · 2011 · 2 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 3 generations on4descendants
- K140533Galaflex MeshTepha, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| 0 (this device) | K080442 | Seriscaffold Surgical Mesh | Serica Technologies, Inc. | 2008 | — |
| +1 | K090288 | Orthadapt PR | Pegasus Biologics, Inc. | 2009 | — |
| +1 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| +2 | K112786 | Proseries Bioimplants-Proankle/Procuff | Synovis Orthopedic and Woundcare, Inc. | 2011 | — |
| +3 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
| +2 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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 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? (4)
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 |
|---|---|---|---|
| * | K810428 | VicrylSummary page 1…urgical mesh is substantially equivalent to predicate surgical mesh products legally marketed in the United States as follows: Bard Mesh® (pre-amendment), VicrylTM Mesh (K8 10428), MersileneTM Mesh (pre-amendment) and Permacol® Surgical Implant (collagen) (K043366). Any minor differences between SeriScaffol… | 1981 |
| * | K043366 | Permacol Surgical ImplantSummary page 1…rketed in the United States as follows: Bard Mesh® (pre-amendment), VicrylTM Mesh (K8 10428), MersileneTM Mesh (pre-amendment) and Permacol® Surgical Implant (collagen) (K043366). Any minor differences between SeriScaffold surgical mesh and the predicate devices do not introduce new safety or performance i… | 2004 |
| * | — | Bard Mesh® Named without a submission number | |
| * | — | Mersilene™ Mesh Named without a submission number |
What descends from it? (14)
See all 142 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 8, 2013 | Class II | Z-0794-2013 | Packaging process control | Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K090288 (Pegasus Biologics, Inc., 2009) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K810428.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
SeriScaffold surgical mesh is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080442: Seriscaffold Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080442
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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