510(k) · Cleared
ClearedCosmatrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tei Biosciences, Inc. · FTM Mesh, Surgical
Cleared on May 17, 2006 as substantially equivalent to K020455 (Tei Biosciences, Inc., 2002) and 2 other predicates after a 51-day review. Its family tree reaches back 4 generations to 1992. 18 later devices descend from it.
- Decided
- May 17, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K921895 (1992). 16 ancestors in all, the oldest K830889 (1983). 18 later devices descend from it, 1 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 backK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- This deviceK060829 CosmatrixTei Biosciences, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 9 of its ownK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 6 of its ownK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
- Descendant · 3 generations on · 5 of its ownK123128 Seri Surgical ScaffoldAllergan · 2013
- Descendant · 4 generations on · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · cites it directly17descendants
- K083898SurgimendTei Biosciences, Inc. · 2009 · 2 generations on9descendants
- K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · 2 generations on6descendants
- K123128Seri Surgical ScaffoldAllergan · 2013 · 3 generations on5descendants
- K140533Galaflex MeshTepha, Inc. · 2014 · 4 generations on3descendants
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 | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| 0 (this device) | K060829 | Cosmatrix | Tei Biosciences, Inc. | 2006 | — |
| +1 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| +2 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| +2 | K081272 | Porcine Surgical Mesh; Dermal Matrix | Brennen Medical, LLC | 2008 | 4 |
| +3 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| +4 | K140533 | Galaflex Mesh | Tepha, Inc. | 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 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K020455 | Tissuemend Soft Tissue Repair MatrixSummary page 1…510(k) Code Number TissueMend FTM TEI Biosciences K020455 Permacol FTM Tissue Science Laboratories K013625 SIS Plastic Surgery Matrix FTM Cook Bi… | 2002 |
| * | K013625 | PermacolSummary page 1…Number TissueMend FTM TEI Biosciences K020455 Permacol FTM Tissue Science Laboratories K013625 SIS Plastic Surgery Matrix FTM Cook Biotech K034039 -… | 2002 |
| * | K034039 | Sis Plastic Surgery MatrixSummary page 1…K020455 Permacol FTM Tissue Science Laboratories K013625 SIS Plastic Surgery Matrix FTM Cook Biotech K034039 - 31 - TEl BIOSCIENCES INC.… | 2004 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071807 | Orthomend Soft Tissue Matrix | 2007 | 17 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K071807 (Tei Biosciences, Inc., 2007) has gone furthest, with 17 descendants of its own.
- 4 other devices also cite its predicate K020455.
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?
CosMatrix is intended for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060829: Cosmatrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060829
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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