510(k) · Cleared
Recalled · 2011Wittmann Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aperta, LLC · FTL Mesh, Surgical, Polymeric
Cleared on Dec 7, 2009 as substantially equivalent to K983753 (Osteogenics, Inc., 1999) after a 62-day review. Its family tree reaches back 1 generation to 1999. It has been recalled 2 times.
- Decided
- Dec 7, 2009
- Review
- 62 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983753 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK983753 Star Temporary Wound CoverOsteogenics, Inc. · 1999
- This deviceK093166 Wittmann PatchAperta, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983753 | Star Temporary Wound Cover | Osteogenics, Inc. | 1999 | — |
| 0 (this device) | K093166 | Wittmann Patch | Aperta, LLC | 2009 | — |
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 |
|---|---|---|---|
| * | K983753 | Star Temporary Wound CoverSummary page 1…the United States: "STAR TEMPORARY WOUND COVER" (Trade name: WITTMANN PATCH) permitted for Osteogenics, Inc. on 11/18/1999 with the 510(k) approval Number K(983753 2) in Europe) CE marketed product: ARTIFICIAL BUR FOR TEMPORARY ABDOMINAL CLOSURE (Trade name: WITTMANN PATCH) permit… | 1999 |
| * | — | ARTIFICIAL BUR FOR TEMPORARY ABDOMINAL CLOSURE (Trade name: WITTMANN PATCH) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2011 | Not classified | Z-0919-2012 | Process change control | On 06/22/2011 Novomedicus, FL initiated a recall of the Artificial Bur Hypopack Lot 1010.1, 1102.1, 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk. |
| Jun 22, 2011 | Not classified | Z-0920-2012 | Process change control | On 06/22/2011 Novomedicus, FL initiated a recall of the Artificial Bur Hypopack Lot 1010.1, 1102.1, 1103.1 and 5643.2. Cytotoxicity testing revealed a biocompatibility issue. The test results did not represent a health risk. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K983753.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
1) Advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease. As fascia expander prosthesis to temporarily close the abdominal cavity when regular abdominal closure is not possible because abdominal organs protrude due to massive swelling of tissues, e.g. abdominal compartment syndrome and other severe and life threatening abdominal pathology.
2) To prevent perfusion impairment of abdominal organs from increased intra-abdominal pressure.
3) Advanced intra-abdominal pathology requiring more than one abdominal operation to control the disease process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093166: Wittmann Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093166
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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