510(k) · Cleared
Recalled · Class II · 2022Surgimesh WN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspide Medical · FTL Mesh, Surgical, Polymeric
Cleared on Feb 1, 2007 as substantially equivalent to K992556 (Tissue Science Laboratories, Plc, 2000) and 2 other predicates after a 253-day review. Its family tree reaches back 3 generations to 2001. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 1, 2007
- Review
- 253 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K011251 (2001). 6 ancestors in all, the oldest K974098 (1998). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 2 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 1 generation backK031767 Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
- This deviceK061445 Surgimesh WNAspide Medical · 2007
- Descendant · cites it directly · 3 of its ownK072974 Surgimesh XBAspide Medical · 2008 · Recalled
- Descendant · 2 generations on · 1 of its ownK093123 Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010
- Descendant · cites it directly · 0 of its ownK120025 Surgimesh XB - SkirtedAspide Medical · 2012
- Descendant · 3 generations on · 0 of its ownK112567 Biomerix AssureBiomerix Corporation · 2011
- Descendant · cites it directly · 0 of its ownK092233 Surgimesh XDAspide Medical · 2010
Most influential descendants
Showing 5 of 5 · See all- K072974Surgimesh XBAspide Medical · 2008 · cites it directly3descendants
- K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010 · 2 generations on1descendant
- K120025Surgimesh XB - SkirtedAspide Medical · 2012 · cites it directly0descendants
- K112567Biomerix AssureBiomerix Corporation · 2011 · 3 generations on0descendants
- K092233Surgimesh XDAspide Medical · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −2 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −1 | K031767 | Mentor Obtape Trans-Obturator Tape | Mentor Corp. | 2003 | — |
| 0 (this device) | K061445 | Surgimesh WN | Aspide Medical | 2007 | — |
| +1 | K072974 | Surgimesh XB | Aspide Medical | 2008 | 2 |
| +2 | K093123 | Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab | Biomerix Corporation | 2010 | — |
| +1 | K120025 | Surgimesh XB - Skirted | Aspide Medical | 2012 | — |
| +3 | K112567 | Biomerix Assure | Biomerix Corporation | 2011 | — |
| +1 | K092233 | Surgimesh XD | Aspide Medical | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 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? (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 |
|---|---|---|---|
| * | K992556 | PermacolSummary page 1…Polymeric Surgical Mesh Classification Name Surgical Mesh Predicate Devices (1) Tissue Science Laboratories' Permacol synthetic mesh (K992556) (2) Davol, Inc.'s Bard Mesh (K033814) (3) Mentor Corp.'s Obtape Mesh (K031767) Intended Use / Indications… | 2000 |
| * | K033814 | Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007Summary page 1…Name Surgical Mesh Predicate Devices (1) Tissue Science Laboratories' Permacol synthetic mesh (K992556) (2) Davol, Inc.'s Bard Mesh (K033814) (3) Mentor Corp.'s Obtape Mesh (K031767) Intended Use / Indications for Use The SURGIMESH®WN implant is r… | 2004 |
| * | K031767 | Mentor Obtape Trans-Obturator TapeSummary page 1…(1) Tissue Science Laboratories' Permacol synthetic mesh (K992556) (2) Davol, Inc.'s Bard Mesh (K033814) (3) Mentor Corp.'s Obtape Mesh (K031767) Intended Use / Indications for Use The SURGIMESH®WN implant is recommended for reinforcement of hernia defects.… | 2003 |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| Aug 12, 2022 | Class II | Z-1983-2025 | Process control | Potential presence of residual adhesive material on the mesh surface. |
| Aug 12, 2022 | Class II | Z-1986-2025 | Process control | Potential presence of residual adhesive material on the mesh surface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K072974 (Aspide Medical, 2008) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K992556.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The SURGIMESH®WN implant is recommended for reinforcement of hernia defects. The hernia repair could be, for example, inguinal hernia, femoral or crural hernia or ventral hernia. The SURGIMESH®WN implant is indicated for use via an extraperitoneal approach either by open or laproscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061445 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061445: Surgimesh WN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061445
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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