510(k) · Cleared
ClearedUltrapro* Hernia System, Models Uhsl, Uhsm, Uhsov
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jun 5, 2007 after a 32-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jun 5, 2007
- Review
- 32 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK071249 Ultrapro* Hernia System, Models Uhsl, Uhsm, UhsovETHICON, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK093932 Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH · 2010
- Descendant · 2 generations on · 3 of its ownK152609 GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK173333 GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK222919 GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK163576 GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K093932Ethicon Physiomesh, Flexible Composite MeshEthicon GmbH · 2010 · cites it directly5descendants
- K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015 · 2 generations on3descendants
- K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. · 2018 · 3 generations on1descendant
- K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. · 2022 · 3 generations on0descendants
- K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071249 | Ultrapro* Hernia System, Models Uhsl, Uhsm, Uhsov | ETHICON, Inc. | 2007 | — |
| +1 | K093932 | Ethicon Physiomesh, Flexible Composite Mesh | Ethicon GmbH | 2010 | — |
| +2 | K152609 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2015 | — |
| +3 | K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018 | — |
| +3 | K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022 | — |
| +3 | K163576 | GORE SYNECOR Preperitoneal Biomaterial | W. L. Gore & Associates, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | — | PROLENE* Hernia System Named without a submission number | |
| * | — | ULTRAPRO* Mesh Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093932 | Ethicon Physiomesh, Flexible Composite Mesh | 2010 | 5 |
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?
- Of its descendants, K093932 (Ethicon GmbH, 2010) has gone furthest, with 5 descendants of its own.
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?
This product is indicated for open repair of abdominal wall hernia defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071249 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071249: Ultrapro* Hernia System, Models Uhsl, Uhsm, Uhsov.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071249
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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