# K093166: Wittmann Patch

- Pathway: 510(k) (Traditional)
- Applicant: Aperta, LLC
- Decided: Dec 7, 2009 after 62 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983753 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983753: Star Temporary Wound Cover, Osteogenics, Inc. (1999) Summary page 1.
- (no number) ARTIFICIAL BUR FOR TEMPORARY ABDOMINAL CLOSURE (Trade name: WITTMANN PATCH): named in the summary without a submission number

## Recalls of this device
- Jun 22, 2011 · Not classified · Z-0919-2012: 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 
- Jun 22, 2011 · Not classified · Z-0920-2012: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K093166
Methodology: https://510kreport.com/methodology