510(k) Report

510(k) · Cleared

Cleared

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

K182259510(k) TraditionalCleared Feb 7, 2019170-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Acell, Inc. · FTM Mesh, Surgical

Cleared on Feb 7, 2019 as substantially equivalent to K162554 (Acell, Inc., 2016) after a 170-day review. Its family tree reaches back 10 generations to 1992.

Decided
Feb 7, 2019
Review
170 days
Class
Class II
Product code
FTM
Recalls
None
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.

Other ancestors, by year cleared 2004: 1 other ancestor2002: 1 other ancestor2000: 5 other ancestors2001: 1 other ancestor1998: 5 other ancestors1997: 3 other ancestors1996: 3 other ancestors1983: 1 other ancestor1992: 1 other ancestor1991: 3 other ancestors1993: 1 other ancestor1988: 1 other ancestor1985: 1 other ancestorReference device: K073391 · Surgisis Biodesign Tissue Graft · Cook Biotech, Inc. · 2008Reference device: K133011 · Diaphragmatic Hernia Graft · Cook Biotech, Inc. · 2014 · recalledK921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K980431 · Surgisis · Cook Biotech, Inc. · 1998K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K001738 · Depuy Restore Orthobiologic Soft Tissue Implant · DePuy Orthopaedics, Inc. · 2000K021637 · Acell Ubm Lyophilized Wound Dressing · Acell, Inc. · 2002×2: 2 generations cleared close together, K040621 (2004), K041140 (2004) K141084 · Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix · Acell, Inc. · 2015K162554 · Gentrix Surgical Matrix · Acell, Inc. · 201619801990200020102020
Other ancestors, by generation 3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 12 other ancestors6 generations back: 7 other ancestors7 generations back: 5 other ancestors K162554 · Gentrix Surgical Matrix · Acell, Inc. · 2016K141084 · Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix · Acell, Inc. · 2015K041140 · Acell Ubm Surgical Mesh ML and Mlplus · Acell, Inc. · 2004K040621 · Acell Ubm Surgical Mesh · Acell, Inc. · 2004K021637 · Acell Ubm Lyophilized Wound Dressing · Acell, Inc. · 2002K001738 · Depuy Restore Orthobiologic Soft Tissue Implant · DePuy Orthopaedics, Inc. · 2000K992159 · Surgisis Sling · Cook Biotech, Inc. · 1999K980431 · Surgisis · Cook Biotech, Inc. · 1998K961810 · Supple Peri-Guard Pericardium · Bio-Vascular, Inc. · 1996K921895 · Tissue Patch, Tissue Graft · Bio-Vascular, Inc. · 1992−10−50
  1. Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 6 generations between
  3. 3 generations backK041140 Acell Ubm Surgical Mesh ML and MlplusAcell, Inc. · 2004
  4. 2 generations backK141084 Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc. · 2015
  5. 1 generation backK162554 Gentrix Surgical MatrixAcell, Inc. · 2016
  6. This deviceK182259 Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc. · 2019
Show all 10 generations
  1. Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  6. 5 generations backK021637 Acell Ubm Lyophilized Wound DressingAcell, Inc. · 2002
  7. 4 generations backK040621 Acell Ubm Surgical MeshAcell, Inc. · 2004
  8. 3 generations backK041140 Acell Ubm Surgical Mesh ML and MlplusAcell, Inc. · 2004
  9. 2 generations backK141084 Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc. · 2015
  10. 1 generation backK162554 Gentrix Surgical MatrixAcell, Inc. · 2016
  11. This deviceK182259 Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−9K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−8K980431SurgisisCook Biotech, Inc.1998—
−7K992159Surgisis SlingCook Biotech, Inc.1999—
−6K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
−5K021637Acell Ubm Lyophilized Wound DressingAcell, Inc.2002—
−4K040621Acell Ubm Surgical MeshAcell, Inc.2004—
−3K041140Acell Ubm Surgical Mesh ML and MlplusAcell, Inc.2004—
−2K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixAcell, Inc.2015—
−1K162554Gentrix Surgical MatrixAcell, Inc.2016—
0 (this device)K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalAcell, Inc.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198810
199130
199210
199310
199630
199730
199850
200050
200110
200210
200410
FIG. 1 — Lineage of K182259, 1992–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K162554Gentrix Surgical Matrix
Summary page 4
…Number: 21 C.F.R. § 878.3300 Regulatory Class: Class II FDA Product Code: FTM, OXH, OWV Predicate Device: Gentrix® Surgical Matrix 2-Layer, 3-Layer, 6- Layer, 8-Layer (K162554) Reference Devices: The SURGISIS® Biodesign Tissue Graft (K073391, Cook Biotech Inc.) Biodesign® Diaphragmatic…
Acell, Inc.2016—
†K073391Surgisis Biodesign Tissue GraftCook Biotech, Inc.2008—
†K133011Diaphragmatic Hernia GraftCook Biotech, Inc.20141

Also cleared against K162554: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 2.0 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 devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FTM

1in 2025

2007: 92008: 92009: 72010: 22011: 62012: 42013: 42014: 82015: 42016: 72017: 92018: 22019: 62020: 42021: 42023: 22024: 32025: 12026 (partial year): 1
2007high 9 (2007) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTM

29in 2024

2007: 104 days median2008: 86 days median2009: 86 days median2011: 100 days median2012: 66 days median2013: 123 days median2014: 153 days median2015: 316 days median2016: 88 days median2017: 147 days median2019: 107 days median2020: 59 days median2021: 61 days median2024: 29 days median
2007high 316 (2015) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTM

1in 2023

2007: 72008: 12010: 12011: 82018: 212019: 42020: 12021: 12023: 1
2007high 21 (2018) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTM

232in 2025

2007: 602008: 1412009: 4762010: 1972011: 2882012: 4672013: 3,3512014: 1,0932015: 9772016: 5092017: 5292018: 3572019: 4182020: 4572021: 3692022: 3752023: 4852024: 3832025: 232
2007high 3,351 (2013) · low 60 (2007)2025

MAUDE reports naming product code FTM, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079104760
20089861141
20097860476
20102—1197
201161008288
20124660467
2013412303,351
2014815301,093
201543160977
20167880509
201791470529
20182—21357
201961074418
20204591457
20214611369
20220—0375
20232—1485
20243290383
20251—0232
20261—0—

What is it indicated for?

Gentrix® Surgical Matrix (3-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue…

Read the full statement (178 words)

Gentrix® Surgical Matrix (3-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following open or laparoscopic procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. The Gentrix® Surgical Matrix (3-layer) minimizes tissue attachment to the device in case of direct contact with viscera.

Gentrix® Surgical Matrix and Gentrix® Surgical Matrix Hiatal (6-layer and 8-Layer) 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 open or laparoscopic procedures: hernia (e.g.: hiatal/diaphragmatic) and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. The Gentrix® Surgical Matrix and Gentrix® Surgical Matrix Hiatal (6-layer and 8-Layer) minimizes tissue attachment to the device in case of direct contact with viscera.

Indications for use as stated in the FDA summary.

Also cleared against K162554

1 other device cites the same predicate.

  • K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendAcell, Inc. · 20172 recalls

More from Acell, Inc.

20 FDA decisions under this applicant name. See the company

  • K241724Cytal® Wound Matrix; Cytal® Burn MatrixAcell, Inc. · 2024
  • K241706MicroMatrix® UBM ParticulateAcell, Inc. · 2024
  • K230980MicroMatrix® FlexAcell, Inc. · 2023
  • K191734MatriStem UBM Pericardial PatchAcell, Inc. · 2019
  • K192725Cytal Wound Matrix 3-LayerAcell, Inc. · 2019

Recent decisions in FTM

The FTM category page

  • K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific · 2026
  • K250598Endoform Reconstructive Template - PLGAAroa Biosurgery, Ltd. · 2025
  • K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc. · 2024
  • K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc. · 2024
  • K241126OviTex PRSTELA Bio, Inc. · 2024

https://510kreport.com/device/K182259 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182259: Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182259

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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