510(k) · Cleared
Recalled · Class II · 2019Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acell, Inc. · FTM Mesh, Surgical
Cleared on Jun 8, 2017 as substantially equivalent to K162554 (Acell, Inc., 2016) after an 87-day review. Its family tree reaches back 10 generations to 1992. It has been recalled 2 times.
- Decided
- Jun 8, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- FTM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 10 generations to K921895 (1992). 37 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 backK041140 Acell Ubm Surgical Mesh ML and MlplusAcell, Inc. · 2004
- 2 generations backK141084 Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc. · 2015
- 1 generation backK162554 Gentrix Surgical MatrixAcell, Inc. · 2016
- This deviceK170763 Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. · 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 backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
- 4 generations backK040621 Acell Ubm Surgical MeshAcell, Inc. · 2004
- 3 generations backK041140 Acell Ubm Surgical Mesh ML and MlplusAcell, Inc. · 2004
- 2 generations backK141084 Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc. · 2015
- 1 generation backK162554 Gentrix Surgical MatrixAcell, Inc. · 2016
- This deviceK170763 Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. · 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 | K021637 | Acell Ubm Lyophilized Wound Dressing | Acell, Inc. | 2002 | — |
| −4 | K040621 | Acell Ubm Surgical Mesh | Acell, Inc. | 2004 | — |
| −3 | K041140 | Acell Ubm Surgical Mesh ML and Mlplus | Acell, Inc. | 2004 | — |
| −2 | K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | Acell, Inc. | 2015 | — |
| −1 | K162554 | Gentrix Surgical Matrix | Acell, Inc. | 2016 | — |
| 0 (this device) | K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | Acell, 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 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K162554 | Gentrix Surgical MatrixSummary page 4…al Mesh Regulatory Class: Class II Product Code: FTM, OXH, OXK Predicate Devices: ACell, Inc. Gentrix™ Surgical Matrix 8 Layer (K162554) Device Description The Gentrix™ Surgical Matrix Thick and Gentrix™ Surgical Matrix Extend devices are composed of porcine-der… | 2016 |
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 |
|---|---|---|---|---|
| Feb 14, 2019 | Class II | Z-1033-2019 | Nonconforming Material/Component | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. |
| Feb 14, 2019 | Class II | Z-1032-2019 | Nonconforming Material/Component | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 37 ancestors has a recall of any class.
- 1 other device also cites its predicate K162554.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170763: Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170763
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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