510(k) · Cleared
ClearedSis Dermal Augmentation Strand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · FTM Mesh, Surgical
Cleared on May 19, 2005 as substantially equivalent to K034039 (Cook Biotech, Inc., 2004) and 3 other predicates after a 106-day review. Its family tree reaches back 4 generations to 1992. 4 later devices descend from it.
- Decided
- May 19, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K921895 (1992). 15 ancestors in all, the oldest K830889 (1983). 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- This deviceK050246 Sis Dermal Augmentation StrandCook Biotech, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK053622 Surgisis Ocular GraftIop, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK090078 Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK223074 CorNeat EverPatchCorneat Vision, Ltd. · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK110402 Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K053622Surgisis Ocular GraftIop, Inc. · 2006 · cites it directly2descendants
- K090078Kerasys Bioengineered Lamellar Patch GraftIop, Inc. · 2009 · cites it directly1descendant
- K223074CorNeat EverPatchCorneat Vision, Ltd. · 2023 · 2 generations on0descendants
- K110402Biodesign Nipple Reconstruction CylinderCook Biotech, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| 0 (this device) | K050246 | Sis Dermal Augmentation Strand | Cook Biotech, Inc. | 2005 | — |
| +1 | K053622 | Surgisis Ocular Graft | Iop, Inc. | 2006 | — |
| +1 | K090078 | Kerasys Bioengineered Lamellar Patch Graft | Iop, Inc. | 2009 | — |
| +2 | K223074 | CorNeat EverPatch | Corneat Vision, Ltd. | 2023 | 3 |
| +1 | K110402 | Biodesign Nipple Reconstruction Cylinder | Cook Biotech, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K034039 | Sis Plastic Surgery MatrixSummary page 1…supplied sterile and is intended for one-time use. Predicate Devices: The SIS Facial Implant is similar to predicate devices, including the SIS Plastic Surgery Matrix (K034039) and SURGISIS® Soft Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, Permacol (KO13625) manufactured by Tissue… | 2004 |
| * | K980431 | SurgisisSummary page 1…time use. Predicate Devices: The SIS Facial Implant is similar to predicate devices, including the SIS Plastic Surgery Matrix (K034039) and SURGISIS® Soft Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, Permacol (KO13625) manufactured by Tissue Science Laboratories, PLC, and Advanta PTFE… | 1998 |
| * | K013625 | Permacol | 2002 |
| * | K992991 | Atrium Medical Corporation Advanta Ptfe Facial ImplantSummary page 1…Tissue Graft (K98043 1) manufactured by Cook Biotech Incorporated, Permacol (KO13625) manufactured by Tissue Science Laboratories, PLC, and Advanta PTFE Facial Implant (K992991) manufactured by Atrium Medical Corporation. Device Description: The SIS Facial Implant is manufactured from porcine small intes… | 2000 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K053622 (Iop, Inc., 2006) has gone furthest, with 2 descendants of its own.
- 11 other devices also cite its predicate K034039.
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 SIS Facial Implant is intended for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head. The device is supplied sterile and is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050246: Sis Dermal Augmentation Strand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050246
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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