510(k) · Cleared

Recalled · Class II · 2022

Surgimesh XB

K072974510(k) TraditionalCleared Aug 18, 2008301-day reviewClass II21 CFR 878.3300Recalls 2

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 Aug 18, 2008 as substantially equivalent to K061445 (Aspide Medical, 2007) and 5 other predicates after a 301-day review. Its family tree reaches back 5 generations to 1993. 3 later devices descend from it. It has been recalled 2 times.

Decided: Aug 18, 2008
Review: 301 days
Class: Class II
Product code: FTL
Recalls: 2
Predicates: 6

Its longest line of descent runs back 5 generations to K931386 (1993). 26 ancestors in all, the oldest K922916 (1992). 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 5 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
4 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
3 generations backK972651 IN-SlingInfluence, Inc. · 1997
2 generations backK980482 Triangle SlingInfluence, Inc. · 1998
1 generation backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
This deviceK072974 Surgimesh XBAspide Medical · 2008
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 ownK120025 Surgimesh XB - SkirtedAspide Medical · 2012
Descendant · 2 generations on · 0 of its ownK112567 Biomerix AssureBiomerix Corporation · 2011

Most influential descendants

Showing 3 of 3 · See all

K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010 · cites it directly1descendant
K120025Surgimesh XB - SkirtedAspide Medical · 2012 · cites it directly0descendants
K112567Biomerix AssureBiomerix Corporation · 2011 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K931386	Hemashield Microvel/Woven Double Velour Fabric	Meadox Medicals, Div. Boston Scientific Corp.	1993	—
−4	K963611	Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…	Vascutek, Ltd.	1996	1
−3	K972651	IN-Sling	Influence, Inc.	1997	—
−2	K980482	Triangle Sling	Influence, Inc.	1998	—
−1	K002721	Ams Triangle Silicone-Coated Sling and Surgical Mesh	American Medical Systems, Inc.	2000	—
0 (this device)	K072974	Surgimesh XB	Aspide Medical	2008	—
+1	K093123	Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab	Biomerix Corporation	2010	—
+1	K120025	Surgimesh XB - Skirted	Aspide Medical	2012	—
+2	K112567	Biomerix Assure	Biomerix Corporation	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1996	2	0
1998	2	0
1999	1	0
2000	2	0
2001	4	0
2002	1	0
2003	1	0
2004	4	0
2005	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K072974, 1993–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K061445	Surgimesh WN Summary page 1 …Name Surgical Mesh Product Code: FTL Regulation Number: 21 C.F.R. 878.3300 Predicate Devices (1) ASPIDE MEDICAL SURGIMESH®WN (K061445) (2) Sofradim Production's Parietex Composite mesh (K040998) (3) AMS triangle silicone-coated sling (K002721)…	Aspide Medical	2007	2
*	K040998	Modification to Parietex Composite (Pco) Mesh Summary page 1 …egulation Number: 21 C.F.R. 878.3300 Predicate Devices (1) ASPIDE MEDICAL SURGIMESH®WN (K061445) (2) Sofradim Production's Parietex Composite mesh (K040998) (3) AMS triangle silicone-coated sling (K002721) (4) Gore-.Tex® DualMesh® PLUS Biomaterial with Holes (K0102…	Sofradim Production	2004	—
*	K002721	Ams Triangle Silicone-Coated Sling and Surgical Mesh Summary page 1 …(1) ASPIDE MEDICAL SURGIMESH®WN (K061445) (2) Sofradim Production's Parietex Composite mesh (K040998) (3) AMS triangle silicone-coated sling (K002721) (4) Gore-.Tex® DualMesh® PLUS Biomaterial with Holes (K010228) (5) Davol Inc., Bard® Soft Mesh (K033814)…	American Medical Systems, Inc.	2000	—
*	K010228	Gore-Tex Dualmesh Plus Biomaterial with Holes Summary page 1 …Production's Parietex Composite mesh (K040998) (3) AMS triangle silicone-coated sling (K002721) (4) Gore-.Tex® DualMesh® PLUS Biomaterial with Holes (K010228) (5) Davol Inc., Bard® Soft Mesh (K033814) (6) Davol Inc., Bard Composix® L/P Mesh (K061754) \\\DC -024SS…	W. L. Gore & Associates, Inc.	2001	—
*	K033814	Bard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 Summary page 1 …(3) AMS triangle silicone-coated sling (K002721) (4) Gore-.Tex® DualMesh® PLUS Biomaterial with Holes (K010228) (5) Davol Inc., Bard® Soft Mesh (K033814) (6) Davol Inc., Bard Composix® L/P Mesh (K061754) \\\DC -024SS6/000001 - 2767007 v1…	C.R. Bard, Inc.	2004	1
*	K061754	Bard Composite L/P Mesh Summary page 1 …(4) Gore-.Tex® DualMesh® PLUS Biomaterial with Holes (K010228) (5) Davol Inc., Bard® Soft Mesh (K033814) (6) Davol Inc., Bard Composix® L/P Mesh (K061754) \\\DC -024SS6/000001 - 2767007 v1…	Davol Inc., Sub. C. R. Bard, Inc.	2006	—

Also cleared against K061445: 2 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093123	Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab	Biomerix Corporation	2010	1
K120025	Surgimesh XB - Skirted	Aspide Medical	2012	0

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-1985-2025	Process control	Potential presence of residual adhesive material on the mesh surface.
Aug 12, 2022	Class II	Z-1984-2025	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 15 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
5 of the 26 ancestors have a recall of any class.
Of its descendants, K093123 (Biomerix Corporation, 2010) has gone furthest, with 1 descendant of its own.
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. 2008, this device’s year, is highlighted.

FDA decisions per year · FTL

6in 2025

2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

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

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

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®XB 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.

https://510kreport.com/device/K072974 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072974: Surgimesh XB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072974

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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