510(k) · Cleared
ClearedAcell Ubm Surgical Mesh ML and Mlplus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acell, Inc. · FTM Mesh, Surgical
Cleared on Jul 7, 2004 as substantially equivalent to K040621 (Acell, Inc., 2004) and 1 other predicate after a 68-day review. Its family tree reaches back 7 generations to 1992. 4 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921895 (1992). 25 ancestors in all, the oldest K830889 (1983). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 3 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 2 generations backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- 1 generation backK040621 Acell Ubm Surgical MeshAcell, Inc. · 2004
- This deviceK041140 Acell Ubm Surgical Mesh ML and MlplusAcell, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK141084 Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK162554 Gentrix Surgical MatrixAcell, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK182259 Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK170763 Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. · 2017 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc. · 2015 · cites it directly3descendants
- K162554Gentrix Surgical MatrixAcell, Inc. · 2016 · 2 generations on2descendants
- K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc. · 2019 · 3 generations on0descendants
- K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −3 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| −1 | K040621 | Acell Ubm Surgical Mesh | Acell, Inc. | 2004 | — |
| 0 (this device) | K041140 | Acell Ubm Surgical Mesh ML and Mlplus | Acell, Inc. | 2004 | — |
| +1 | K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | Acell, Inc. | 2015 | — |
| +2 | K162554 | Gentrix Surgical Matrix | Acell, Inc. | 2016 | — |
| +3 | K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Acell, Inc. | 2019 | — |
| +3 | K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | Acell, Inc. | 2017 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040621 | Acell Ubm Surgical MeshSummary page 1…ACelI UBM Surgical Mesh ML and MLPIus Device Common Surgical mesh Name: Classification Name: Mesh, Surgical (FTM; 21 CFR 878.3300) Predicate Devices: K040621; ACeII, Inc., ACei UBM Surgical Mesh K992159; Cook Biotech, Inc., Surgisistm Sling Device Description:… | 2004 |
| * | K992159 | Surgisis SlingSummary page 1…ical mesh Name: Classification Name: Mesh, Surgical (FTM; 21 CFR 878.3300) Predicate Devices: K040621; ACeII, Inc., ACei UBM Surgical Mesh K992159; Cook Biotech, Inc., Surgisistm Sling Device Description: The ACeII UBM Surgical Mesh ML and MLPIus are composed of porcine… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | 2015 | 3 |
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 12 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K141084 (Acell, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K040621.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ACell UBM Surgical Mesh ML and MLPIus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethral support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041140: Acell Ubm Surgical Mesh ML and Mlplus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041140
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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