510(k) · Cleared
Recalled · Class II · 2023Orthomend Soft Tissue 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 Aug 6, 2007 as substantially equivalent to K051766 (Tei Biosciences, Inc., 2005) and 2 other predicates after a 35-day review. Its family tree reaches back 8 generations to 1992. 17 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 6, 2007
- Review
- 35 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 8 generations to K921895 (1992). 40 ancestors in all, the oldest K830889 (1983). 17 later devices descend from it, 2 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 deviceK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- Descendant · cites it directly · 6 of its ownK081272 Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · Recalled
- Descendant · 2 generations on · 5 of its ownK123128 Seri Surgical ScaffoldAllergan · 2013
- Descendant · 3 generations on · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K083898SurgimendTei Biosciences, Inc. · 2009 · cites it directly9descendants
- K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 2008 · cites it directly6descendants
- K123128Seri Surgical ScaffoldAllergan · 2013 · 2 generations on5descendants
- K140533Galaflex MeshTepha, Inc. · 2014 · 3 generations on3descendants
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 2 generations on2descendants
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) | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | — |
| +1 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| +1 | K081272 | Porcine Surgical Mesh; Dermal Matrix | Brennen Medical, LLC | 2008 | 4 |
| +2 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| +3 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +2 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
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 | 3 | 0 |
| 1998 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051766 | OrthomendSummary page 2…lent in function and intended use to: Predicate Device Manufacturer 510(k) Number OrthoMend TEl Biosciences K051766 CosMatrix TEI Biosciences K<060829 TissueMend TEI Biosciences K020… | 2005 |
| * | K060829 | CosmatrixSummary page 2…Manufacturer 510(k) Number OrthoMend TEl Biosciences K051766 CosMatrix TEI Biosciences K<060829 TissueMend TEI Biosciences K020455 OrthADAPT Pegasus BiologicsK71065 Summary of Tech… | 2006 |
| * | K020455 | Tissuemend Soft Tissue Repair MatrixSummary page 2…TEl Biosciences K051766 CosMatrix TEI Biosciences K<060829 TissueMend TEI Biosciences K020455 OrthADAPT Pegasus BiologicsK71065 Summary of Technological Characteristics and Biocompatibility SurgiMend is su… | 2002 |
| Kept off the family tree | K071065 | FDA’s K071065 is Orthadapt Bioimplant Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2007 |
What descends from it? (17)
See all 172 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2023 | Class II | Z-2070-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Class II | Z-2083-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Class II | Z-2069-2023 | Under Investigation by firm | Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing. |
| May 23, 2023 | Class II | Z-2071-2023 | 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 15 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 40 ancestors has a recall of any class.
- Of its descendants, K083898 (Tei Biosciences, Inc., 2009) has gone furthest, with 9 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. 2007, this device’s year, is highlighted.
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?
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. SurgiMend is specifically indicated for: * Plastic and reconstructive surgery * Muscle flap reinforcement * Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias * Reinforcement of soft tissues repaired by sutures or suture anchors, during…
Read the full statement (135 words)
SurgiMend is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
SurgiMend is specifically indicated for:
* Plastic and reconstructive surgery
* Muscle flap reinforcement
* Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias
* 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. SurgiMend 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071807: Orthomend Soft Tissue Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071807
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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