510(k) · Cleared
ClearedSis Plastic Surgery Matrix
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 Feb 18, 2004 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) and 2 other predicates after a 51-day review. Its family tree reaches back 3 generations to 1992. 93 later devices descend from it.
- Decided
- Feb 18, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921895 (1992). 14 ancestors in all, the oldest K830889 (1983). 93 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
- This deviceK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
- Descendant · cites it directly · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- Descendant · cites it directly · 18 of its ownK060829 CosmatrixTei Biosciences, Inc. · 2006
- Descendant · 2 generations on · 17 of its ownK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 14 of its ownK082176 LTM-BPS Surgical MeshLifecell Corp. · 2008
- Descendant · 3 generations on · 11 of its ownK142326 HP Tissue MatrixLifecell Corporation · 2014
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K070560LRTM Surgical MeshLifecell Corp. · 2007 · cites it directly50descendants
- K060829CosmatrixTei Biosciences, Inc. · 2006 · cites it directly18descendants
- K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · 2 generations on17descendants
- K082176LTM-BPS Surgical MeshLifecell Corp. · 2008 · 2 generations on14descendants
- K142326HP Tissue MatrixLifecell Corporation · 2014 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| 0 (this device) | K034039 | Sis Plastic Surgery Matrix | Cook Biotech, Inc. | 2004 | — |
| +1 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| +1 | K060829 | Cosmatrix | Tei Biosciences, Inc. | 2006 | — |
| +2 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| +2 | K082176 | LTM-BPS Surgical Mesh | Lifecell Corp. | 2008 | — |
| +3 | K142326 | HP Tissue Matrix | Lifecell Corporation | 2014 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 10 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 10 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 1…sterile and is intended for one-time use. Predicate Devices: The SIS Plastic Surgery Matrix is similar to predicate devices, including the SURGISIS' Soft Tissue Graft (K98043 1) nmanufactured by Cook Biotech Incorporated, Permnacol (KOI1 3625) manufactured by Tissue Science Laboratories, PLC, and Advanita… | 1998 |
| * | K013625 | Permacol | 2002 |
| * | K992991 | Atrium Medical Corporation Advanta Ptfe Facial ImplantSummary page 1…ue Graft (K98043 1) nmanufactured by Cook Biotech Incorporated, Permnacol (KOI1 3625) manufactured by Tissue Science Laboratories, PLC, and Advanita PTFE Facial Implant (K992991) manufactured by Atrium Medical Corporation. Device Description: The SIS Plastic Surgery Matrix is manufactured firom porcine… | 2000 |
What descends from it? (93)
See all 9312 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070560 | LRTM Surgical Mesh | 2007 | 50 |
| K060829 | Cosmatrix | 2006 | 18 |
| K094061 | Kensey Nash Ecm Surgical Patch | 2010 | 10 |
| K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | 2016 | 6 |
| K163217 | GORE BIO-A Tissue Reinforcement | 2017 | 5 |
| K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix… | 2019 | 4 |
| K050246 | Sis Dermal Augmentation Strand | 2005 | 4 |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | 2015 | 3 |
| K082079 | Regen Collagen Scaffold (CS) | 2008 | 2 |
| K053622 | Surgisis Ocular Graft | 2006 | 2 |
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 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K070560 (Lifecell Corp., 2007) has gone furthest, with 50 descendants of its own.
- 28 other devices also cite its predicate K980431.
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 Plastic Surgery Matrix Is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. 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/K034039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034039: Sis Plastic Surgery Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034039
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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