510(k) · Cleared
ClearedTissuemend Soft Tissue Repair Matrix
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 Apr 3, 2002 as substantially equivalent to K992556 (Tissue Science Laboratories, Plc, 2000) and 1 other predicate after a 51-day review. Its family tree reaches back 3 generations to 1992. 56 later devices descend from it.
- Decided
- Apr 3, 2002
- Review
- 51 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K921895 (1992). 7 ancestors in all, the oldest K830889 (1983). 56 later devices descend from it, 5 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 deviceK020455 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2002
- Descendant · cites it directly · 36 of its ownK031188 OrthomendTei Biosciences, Inc. · 2003
- Descendant · 2 generations on · 35 of its ownK051766 OrthomendTei Biosciences, Inc. · 2005
- Descendant · cites it directly · 18 of its ownK060829 CosmatrixTei Biosciences, Inc. · 2006
- Descendant · cites it directly · 17 of its ownK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- Descendant · cites it directly · 15 of its ownK051405 Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K031188OrthomendTei Biosciences, Inc. · 2003 · cites it directly36descendants
- K051766OrthomendTei Biosciences, Inc. · 2005 · 2 generations on35descendants
- K060829CosmatrixTei Biosciences, Inc. · 2006 · cites it directly18descendants
- K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · cites it directly17descendants
- K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc. · 2005 · cites it directly15descendants
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) | K020455 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2002 | — |
| +1 | K031188 | Orthomend | Tei Biosciences, Inc. | 2003 | — |
| +2 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| +1 | K060829 | Cosmatrix | Tei Biosciences, Inc. | 2006 | — |
| +1 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| +1 | K051405 | Regensis Pericardial Patch | Cormatrix Cardiovascular, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K992556 | PermacolSummary page 1…Being Claimed TissueMend™ is substantially equivalent in function and intended use to: Predicate Devices Manufacturer 510(k) Number Permacol Tissue Science Laboratories K992556 Surgisis - Cook Biotech K980431 Summary of Technoflogical Characteristics and Biocompatibility -28 - K.o20455 g… | 2000 |
| * | K980431 | SurgisisSummary page 1…stantially equivalent in function and intended use to: Predicate Devices Manufacturer 510(k) Number Permacol Tissue Science Laboratories K992556 Surgisis - Cook Biotech K980431 Summary of Technoflogical Characteristics and Biocompatibility -28 - K.o20455 g e TEI BIOSCIENCES INC. TissueM… | 1998 |
What descends from it? (56)
See all 565 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 10 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K031188 (Tei Biosciences, Inc., 2003) has gone furthest, with 36 descendants of its own.
- 7 other devices also cite its predicate K992556.
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?
TissueMend™ is intended for use as a soft tissue patch to
reinforce soft tissue where weakness exists and for the surgical repair of damaged or
ruptured soft tissue membranes. It is specifically indicated for the repair of
abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, and incisional
hernias; colon, rectal, urethral, and vaginal prolapse; muscle flap reinforcement;
reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and
urethral sling.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020455: Tissuemend Soft Tissue Repair Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020455
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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