510(k) · Cleared
Recalled · Class II · 2023Surgimend
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 Feb 4, 2009 as substantially equivalent to K071807 (Tei Biosciences, Inc., 2007) after a 37-day review. Its family tree reaches back 9 generations to 1992. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 4, 2009
- Review
- 37 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 9 generations to K921895 (1992). 41 ancestors in all, the oldest K830889 (1983). 9 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations between
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 1 generation backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- This deviceK083898 SurgimendTei Biosciences, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK123128 Seri Surgical ScaffoldAllergan · 2013
- Descendant · 2 generations on · 3 of its ownK140533 Galaflex MeshTepha, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK161092 GalaSHAPE 3DTepha, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK202425 SurgiLattice scaffoldTepha, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK172545 SERI ContourSofregen Medical, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 6 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 5 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 4 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 3 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 2 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 1 generation backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- This deviceK083898 SurgimendTei Biosciences, Inc. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K123128Seri Surgical ScaffoldAllergan · 2013 · cites it directly5descendants
- K140533Galaflex MeshTepha, Inc. · 2014 · 2 generations on3descendants
- K161092GalaSHAPE 3DTepha, Inc. · 2016 · 3 generations on1descendant
- K202425SurgiLattice scaffoldTepha, Inc. · 2021 · 3 generations on0descendants
- K172545SERI ContourSofregen Medical, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −8 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −6 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −5 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −3 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −2 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −1 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| 0 (this device) | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | — |
| +1 | K123128 | Seri Surgical Scaffold | Allergan | 2013 | — |
| +2 | K140533 | Galaflex Mesh | Tepha, Inc. | 2014 | — |
| +3 | K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016 | 1 |
| +3 | K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021 | — |
| +2 | K172545 | SERI Contour | Sofregen Medical, Inc. | 2017 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071807 | Orthomend Soft Tissue MatrixSummary page 2…n function and intended use to: Predicate Device Manufacturer 510(k) Number SurgiMend TEI Biosciences K071807 TissueMend TEI Biosciences K020488 Summary of Technological Characteristics and Biocompatibili… | 2007 |
| Kept off the family tree | K020488 | FDA’s K020488 is Careside Trglyceride Our reading of the summary gave K020488, FDA’s number for Careside Trglyceride (Careside, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “TissueMend”. Kept off the family tree. Summary page 2…facturer 510(k) Number SurgiMend TEI Biosciences K071807 TissueMend TEI Biosciences K020488 Summary of Technological Characteristics and Biocompatibility SurgiMend is substantially equivalent to other surgical meshes… | 2002 |
What descends from it? (9)
4 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-2074-2023 | 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-2075-2023 | 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-2072-2023 | 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 17 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 41 ancestors have a recall of any class.
- Of its descendants, K123128 (Allergan, 2013) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K071807.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083898 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083898: Surgimend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083898
Report an extraction error
Are you the manufacturer?
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