510(k) · Cleared
ClearedBiomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerix Corporation · FTL Mesh, Surgical, Polymeric
Cleared on Jan 7, 2009 as substantially equivalent to K001122 (ETHICON, Inc., 2000) and 4 other predicates after a 97-day review. Its family tree reaches back 9 generations to 1992. 3 later devices descend from it.
- Decided
- Jan 7, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K921895 (1992). 63 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- This deviceK082941 Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009
- Descendant · cites it directly · 1 of its ownK093123 Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010
- Descendant · cites it directly · 0 of its ownK112499 Biomerix Composite Surgical MeshBiomerix Corporation · 2011
- Descendant · 2 generations on · 0 of its ownK112567 Biomerix AssureBiomerix Corporation · 2011
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK052830 SportmeshArtimplant AB · 2006
- 1 generation backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- This deviceK082941 Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −1 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| 0 (this device) | K082941 | Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 | Biomerix Corporation | 2009 | — |
| +1 | K093123 | Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab | Biomerix Corporation | 2010 | — |
| +1 | K112499 | Biomerix Composite Surgical Mesh | Biomerix Corporation | 2011 | — |
| +2 | K112567 | Biomerix Assure | Biomerix Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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? (6)
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 |
|---|---|---|---|
| * | K001122 | Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh | 2000 |
| * | K070961 | Biomerix Surgical Mesh, Model: RCR-01Summary page 1…122) Ethicon Mersilene Polyester Fiber Mesh (pre- amendment) Biomerix Surgical Mesh (K070961) Bard Composix L/P Mesh (K061754) W.L. Gore GORETEX® DualMesh® Biomateria… | 2008 |
| * | K061754 | Bard Composite L/P MeshSummary page 1…Fiber Mesh (pre- amendment) Biomerix Surgical Mesh (K070961) Bard Composix L/P Mesh (K061754) W.L. Gore GORETEX® DualMesh® Biomaterial (K992189)… | 2006 |
| * | K992189 | Gore-Tex Dualmesh BiomaterialSummary page 1…(K070961) Bard Composix L/P Mesh (K061754) W.L. Gore GORETEX® DualMesh® Biomaterial (K992189) AMS InteMesh T M (K042592) Device Description Biomerix Composite Surgical Mesh is a non-ab… | 1999 |
| * | K042592 | Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304Summary page 1…P Mesh (K061754) W.L. Gore GORETEX® DualMesh® Biomaterial (K992189) AMS InteMesh T M (K042592) Device Description Biomerix Composite Surgical Mesh is a non-absorbable porous polymer sca… | 2004 |
| * | — | Ethicon Mersilene Polyester Fiber Mesh Named without a submission number |
What descends from it? (3)
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 17 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 63 ancestors have a recall of any class.
- Of its descendants, K093123 (Biomerix Corporation, 2010) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K001122.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082941 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082941: Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082941
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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