510(k) Report

510(k) · Cleared

Cleared

Surgimesh XB - Skirted

K120025510(k) SpecialCleared Jun 26, 2012175-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aspide Medical · FTL Mesh, Surgical, Polymeric

Cleared on Jun 26, 2012 as substantially equivalent to K072974 (Aspide Medical, 2008) and 3 other predicates after a 175-day review. Its family tree reaches back 6 generations to 1993.

Decided
Jun 26, 2012
Review
175 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K931386 (1993). 31 ancestors in all, the oldest K922916 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2007: 1 other ancestor1999: 2 other ancestors2006: 1 other ancestor2005: 2 other ancestors2004: 4 other ancestors2003: 1 other ancestor2001: 5 other ancestors2000: 2 other ancestors1998: 2 other ancestors1996: 2 other ancestors1992: 1 other ancestor2002: 1 other ancestorK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK972651 · IN-Sling · Influence, Inc. · 1997K980482 · Triangle Sling · Influence, Inc. · 1998K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K072974 · Surgimesh XB · Aspide Medical · 2008 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 8 other ancestors3 generations back: 10 other ancestors4 generations back: 3 other ancestors5 generations back: 1 other ancestor K072974 · Surgimesh XB · Aspide Medical · 2008 · recalledK002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K980482 · Triangle Sling · Influence, Inc. · 1998K972651 · IN-Sling · Influence, Inc. · 1997K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993−50
  1. Root · 6 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 5 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 4 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 3 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 2 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. 1 generation backK072974 Surgimesh XBAspide Medical · 2008 · Recalled
  7. This deviceK120025 Surgimesh XB - SkirtedAspide Medical · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−5K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−4K972651IN-SlingInfluence, Inc.1997—
−3K980482Triangle SlingInfluence, Inc.1998—
−2K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
−1K072974Surgimesh XBAspide Medical20082
0 (this device)K120025Surgimesh XB - SkirtedAspide Medical2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199620
199820
199920
200020
200150
200210
200310
200440
200520
200610
200710
201110
FIG. 1 — Lineage of K120025, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K072974Surgimesh XB
Summary page 2
…fied predicate device specifications. Substantial Equivalence The SURGIMESH®XB - Skirted is substantially equivalent to; (1) Apide Medical's SURGIMESHOXB3 (K072974); (2) Aspide Medical's SIJRGIMESH®WN (K(061445); (3) Gore's DUALWMSH (K(992189); and (4) Cavidien's PARIBTEX COMPOSIT…
Aspide Medical20082
*K061445Surgimesh WN
Summary page 1
…al Mesh Classification Name- Surgical Mesh Predicate Devices (1) Apide Medical's SURGIMEESH@XB (K(072974); (2) Aspide Medical's SURGIMvESH®DWN (K(061445); (3) Gore's DUALIMESH (K(992189); and (4) Covidien's PARIETEX COMPOSITE OPEN ("PCO") SKIRT Mesh (KI110816). Intend…
Aspide Medical20072
*K992189Gore-Tex Dualmesh Biomaterial
Summary page 1
…rgical Mesh Predicate Devices (1) Apide Medical's SURGIMEESH@XB (K(072974); (2) Aspide Medical's SURGIMvESH®DWN (K(061445); (3) Gore's DUALIMESH (K(992189); and (4) Covidien's PARIETEX COMPOSITE OPEN ("PCO") SKIRT Mesh (KI110816). Intended Use / Indications for Use The…
W. L. Gore & Associates, Inc.1999—
*K110816Parietex Optimized Composite Mesh (Pco-Osx References)
Summary page 2
…OXB3 (K072974); (2) Aspide Medical's SIJRGIMESH®WN (K(061445); (3) Gore's DUALWMSH (K(992189); and (4) Cavidien's PARIBTEX COMPOSITE OPEN ("PCO") SKIRT Mesh (K1 10816). The SURGIMESH®XB - Skirted has the same intended uses and similar indications, technological characteristics, and…
Sofradim Production2011—

Also cleared against K072974: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
  • 7 of the 31 ancestors have a recall of any class.
  • 1 other device also cites its predicate K072974.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

The SURGIMESH®XB - Skirted mesh is intended for use in the reinforcement of tissues during surgical repair.

The SURGIMESH®XB-Skirted is indicated for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera

Indications for use as stated in the FDA summary.

Also cleared against K072974

1 other device cites the same predicate.

  • K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010

More from Aspide Medical

4 FDA decisions under this applicant name. See the company

  • K092233Surgimesh XDAspide Medical · 2010
  • K072974Surgimesh XBAspide Medical · 20082 recalls
  • K061445Surgimesh WNAspide Medical · 20072 recalls

Recent decisions in FTL

The FTL category page

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  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K120025 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120025: Surgimesh XB - Skirted.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120025

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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