510(k) · Cleared
Recalled · Class II · 2023SurgiMend PRS Meshed, Revize-X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Lifesciences Corporation (Owner of Tei Biosciences) · OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Cleared on Jun 7, 2017 as substantially equivalent to K083898 (Tei Biosciences, Inc., 2009) after a 29-day review. Its family tree reaches back 10 generations to 1992. It has been recalled 2 times.
- Decided
- Jun 7, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- OXH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921895 (1992). 42 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 1 generation backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- This deviceK171357 SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences) · 2017
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 3 generations backK051766 OrthomendTei Biosciences, Inc. · 2005
- 2 generations backK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled
- 1 generation backK083898 SurgimendTei Biosciences, Inc. · 2009 · Recalled
- This deviceK171357 SurgiMend PRS Meshed, Revize-XIntegra Lifesciences Corporation (Owner of Tei Biosciences) · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −3 | K051766 | Orthomend | Tei Biosciences, Inc. | 2005 | — |
| −2 | K071807 | Orthomend Soft Tissue Matrix | Tei Biosciences, Inc. | 2007 | 4 |
| −1 | K083898 | Surgimend | Tei Biosciences, Inc. | 2009 | 3 |
| 0 (this device) | K171357 | SurgiMend PRS Meshed, Revize-X | Integra Lifesciences Corporation (Owner of Tei Biosciences) | 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 |
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 OXH? 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 OXH device
- #1 K202430 Kerecis Reconstructscore 12.1 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K083898 | SurgimendSummary page 5…Product Trade Name Manufacturer Number Code SurgiMend Collagen Matrix for K083898 FTM TEI Biosciences Inc. Soft Tissue Re… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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-2084-2023 | 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 25 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 42 ancestors have a recall of any class.
- 3 other devices also cite its predicate K083898.
How does its category compare?
All OXH devicesOXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OXH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXH
Too few OXH 510(k)s in any year since 2007 to give a median.
Recalls per year · OXH
No recall names OXH since 2007.
Adverse event reports per year · OXH
2in 2025
MAUDE reports naming product code OXH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SurgiMend® Meshed is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes. SurgiMend® Meshed is specifically indicated for plastic and reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171357: SurgiMend PRS Meshed, Revize-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171357
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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