510(k) · Cleared
Recalled · Class II · 2023Tissuemend 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 May 15, 2006 as substantially equivalent to K051766 (Tei Biosciences, Inc., 2005) after a 35-day review. Its family tree reaches back 8 generations to 1992. 13 later devices descend from it. It has been recalled once.
- Decided
- May 15, 2006
- Review
- 35 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921895 (1992). 32 ancestors in all, the oldest K830889 (1983). 13 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 2 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 1 generation backK051766 OrthomendTei Biosciences, Inc. · 2005
- This deviceK060989 Tissuemend Soft Tissue Repair MatrixTei Biosciences, Inc. · 2006
- Descendant · cites it directly · 12 of its ownK063648 Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007
- Descendant · 2 generations on · 10 of its ownK072190 Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008
- Descendant · 3 generations on · 9 of its ownK083823 Securian Tissue Reinforcement MatrixXylos Corporation · 2009
- Descendant · 4 generations on · 5 of its ownK111584 Xylos Macro-Porous Surgical MeshXylos Corporation · 2011
- Descendant · 5 generations on · 4 of its ownK220091 Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc. · 2007 · cites it directly12descendants
- K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery · 2008 · 2 generations on10descendants
- K083823Securian Tissue Reinforcement MatrixXylos Corporation · 2009 · 3 generations on9descendants
- K111584Xylos Macro-Porous Surgical MeshXylos Corporation · 2011 · 4 generations on5descendants
- K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd. · 2022 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −2 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −1 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| 0 (this device) | K060989 | Tissuemend Soft Tissue Repair Matrix | Tei Biosciences, Inc. | 2006 | — |
| +1 | K063648 | Surgi-Wrap Mast Tendon Sheet | Mast Biosurgery USA, Inc. | 2007 | — |
| +2 | K072190 | Ortho-Wrap Bioresorbable Sheet | Mast Biosurgery | 2008 | — |
| +3 | K083823 | Securian Tissue Reinforcement Matrix | Xylos Corporation | 2009 | — |
| +4 | K111584 | Xylos Macro-Porous Surgical Mesh | Xylos Corporation | 2011 | — |
| +5 | K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | Xiros, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K051766 | OrthomendSummary page 2…d intended use to: Predicate Manufacturer 510(k) Number Devices OrthoMend TH Biosciences K051766 Summary of Technological Characteristics and Biocompatibility TissueMend is substantially equivalent to other wound dressin… | 2005 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063648 | Surgi-Wrap Mast Tendon Sheet | 2007 | 12 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2023 | Class II | Z-2085-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 32 ancestors has a recall of any class.
- Of its descendants, K063648 (Mast Biosurgery USA, Inc., 2007) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K051766.
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 Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. TissueMend Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps…
Read the full statement (117 words)
TissueMend Soft Tissue Repair Matrix is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
TissueMend Soft Tissue Repair Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. TissueMend Soft Tissue Repair Matrix reinforces soft tissue and provides a remodelable scaffold that is replaced by the patient's own soft tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060989: Tissuemend Soft Tissue Repair Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060989
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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