510(k) Report

510(k) · Cleared

Cleared

Surgimesh XD

K092233510(k) TraditionalCleared Jun 25, 2010337-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 25, 2010 as substantially equivalent to K061445 (Aspide Medical, 2007) and 2 other predicates after a 337-day review. Its family tree reaches back 4 generations to 2001.

Decided
Jun 25, 2010
Review
337 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K011251 (2001). 10 ancestors in all, the oldest K974098 (1998). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2002: 1 other ancestor2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestorK011251 · Sparc Sling System · American Medical Systems, Inc. · 2001K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K031767 · Mentor Obtape Trans-Obturator Tape · Mentor Corp. · 2003K061445 · Surgimesh WN · Aspide Medical · 2007 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors K061445 · Surgimesh WN · Aspide Medical · 2007 · recalledK031767 · Mentor Obtape Trans-Obturator Tape · Mentor Corp. · 2003K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K011251 · Sparc Sling System · American Medical Systems, Inc. · 20010
  1. Root · 4 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 3 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 2 generations backK031767 Mentor Obtape Trans-Obturator TapeMentor Corp. · 2003
  4. 1 generation backK061445 Surgimesh WNAspide Medical · 2007 · Recalled
  5. This deviceK092233 Surgimesh XDAspide Medical · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−3K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−2K031767Mentor Obtape Trans-Obturator TapeMentor Corp.2003—
−1K061445Surgimesh WNAspide Medical20072
0 (this device)K092233Surgimesh XDAspide Medical2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200110
200210
200410
200810
FIG. 1 — Lineage of K092233, 2001–2010Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K061445Surgimesh WN
Summary page 1
…RANCE) Common or Usual Name Polymeric Surgical Mesh Classification Name Surgical Mesh Predicate Devices (1) ASPIDE MEDICAL's SURGIMIESH WN (K061445); (2) BAR-D's 3D MAX (K(08 1010); and (3) PROMEDON's SAFYRE SLING (K020007). Intended Use / Indications for Use The SUR…
Aspide Medical20072
*K081010Bard 3DMAX Mesh
Summary page 2
…, 1999). Substantial Equivalence The SUROIMESHSXD is substantially equivalent to: (1) ASPIDE MEDICAL's SURGIMESH WN (K(061445); (2) BARD's 3D MAX (1(081010); and (3) PROMEDON's SAFYRE SLING (KO020007). The SURGIMESH®XD has the same intended uses and similar indicati…
Davol Inc., Sub. C. R. Bard, Inc.2008—
*K020007Safyre Sling System
Summary page 1
…e Surgical Mesh Predicate Devices (1) ASPIDE MEDICAL's SURGIMIESH WN (K061445); (2) BAR-D's 3D MAX (K(08 1010); and (3) PROMEDON's SAFYRE SLING (K020007). Intended Use / Indications for Use The SURGIMESI-I®XD mesh is recommended for reinforcement of hernia defects. The hernia rep…
Promedon2002—

Also cleared against K061445: 2 other devices →

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 9 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K061445.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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®)XD mesh is recommended for reinforcement of hernia defects. The hernia repair is for an inguinal hernia. The SURGIMESH®XD implant is indicated for use via an extraperitoneal approach either by open or laparoscopic surgery.

Indications for use as stated in the FDA summary.

Also cleared against K061445

2 other devices cite the same predicate.

  • K120025Surgimesh XB - SkirtedAspide Medical · 2012
  • K072974Surgimesh XBAspide Medical · 20082 recalls

More from Aspide Medical

4 FDA decisions under this applicant name. See the company

  • K120025Surgimesh XB - SkirtedAspide Medical · 2012
  • K072974Surgimesh XBAspide Medical · 20082 recalls
  • K061445Surgimesh WNAspide Medical · 20072 recalls

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • 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/K092233 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092233: Surgimesh XD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092233

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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