510(k) Report

510(k) · Cleared

Cleared

Dermmatrix Surgical Mesh

K021160510(k) TraditionalCleared Jun 12, 200262-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

Carbon Medical Technologies, Inc. · FTM Mesh, Surgical

Cleared on Jun 12, 2002 as substantially equivalent to K993459 (Advanced Uroscience, Inc., 1999) and 2 other predicates after a 62-day review. Its family tree reaches back 4 generations to 1992. 38 later devices descend from it.

Decided
Jun 12, 2002
Review
62 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K921895 (1992). 13 ancestors in all, the oldest K830889 (1983). 38 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1997: 1 other ancestor1983: 1 other ancestor1992: 1 other ancestor2005: 2 descendants cleared2008: 7 descendants cleared2006: 1 descendant cleared2011: 3 descendants cleared2014: 2 descendants cleared2007: 1 descendant cleared2016: 3 descendants cleared2012: 4 descendants cleared2015: 1 descendant cleared2009: 2 descendants cleared2013: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2025: 3 descendants cleared2026: 3 descendants cleared2024: 1 descendant clearedK921895 · 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. · 199919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 10 descendants4 generations forward: 7 descendants5 generations forward: 4 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants K992159 · 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. · 19920+5
  1. Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 1 generation backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. This deviceK021160 Dermmatrix Surgical MeshCarbon Medical Technologies, Inc. · 2002
  6. Descendant · cites it directly · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
  7. Descendant · 2 generations on · 17 of its ownK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
  8. Descendant · 2 generations on · 12 of its ownK073219 WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT…American Medical Systems, Inc. · 2008
  9. Descendant · 3 generations on · 11 of its ownK120019 Collagen RibbonWrightmedicaltechnologyinc · 2012
  10. Descendant · 3 generations on · 11 of its ownK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 12008: 72009: 22011: 32012: 42013: 12014: 22015: 12016: 32022: 22023: 22024: 12025: 32026: 3
2005high 7 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 38 · See all
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · cites it directly30descendants
  • K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005 · 2 generations on17descendants
  • K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6…American Medical Systems, Inc. · 2008 · 2 generations on12descendants
  • K120019Collagen RibbonWrightmedicaltechnologyinc · 2012 · 3 generations on11descendants
  • K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP…American Medical Systems, Inc. · 2008 · 3 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−3K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−2K980431SurgisisCook Biotech, Inc.1998—
−1K992159Surgisis SlingCook Biotech, Inc.1999—
0 (this device)K021160Dermmatrix Surgical MeshCarbon Medical Technologies, Inc.2002—
+1K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051
+2K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc.2005—
+2K073219WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal…American Medical Systems, Inc.2008—
+3K120019Collagen RibbonWrightmedicaltechnologyinc2012—
+3K080185Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen…American Medical Systems, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199210
199620
199710
199820
199910
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200710
200870
200920
201130
201240
201310
201420
201510
201630
202220
202320
202410
202530
202630
FIG. 1 — Lineage of K021160, 1992–2026Source: 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? (3)

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
*K993459Modification to Brennen Biosynthetic Surgical Mesh Matrix
Summary page 1
…Surgical Mesh, 21 CFR 878.3300 CommodUsual Name: Surgical Mesh Predicate Devices Carbon Medical Technologies DermMatrix Surgical Mesh [K9934591 Tissue Science Laboratories Permacol (marketed by Bard as Pelvicol) [K992556] Cook Biotech, Inc. Surgisis Sling [K992159] Indic…
Advanced Uroscience, Inc.1999—
*K992556Permacol
Summary page 1
…Surgical Mesh Predicate Devices Carbon Medical Technologies DermMatrix Surgical Mesh [K9934591 Tissue Science Laboratories Permacol (marketed by Bard as Pelvicol) [K992556] Cook Biotech, Inc. Surgisis Sling [K992159] Indication for Use Intended for use in the treatment of hernias where the connecti…
Tissue Science Laboratories, Plc2000—
*K992159Surgisis Sling
Summary page 1
…Medical Technologies DermMatrix Surgical Mesh [K9934591 Tissue Science Laboratories Permacol (marketed by Bard as Pelvicol) [K992556] Cook Biotech, Inc. Surgisis Sling [K992159] Indication for Use Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation t…
Cook Biotech, Inc.1999—

Also cleared against K993459: 2 other devices →

What descends from it? (38)

See all 38

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.200530
K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC20086

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 10 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • None of the 13 ancestors has a recall.
  • Of its descendants, K050445 (American Medical Systems, Inc., 2005) has gone furthest, with 30 descendants of its own.
  • 2 other devices also cite its predicate K993459.

How does its category compare?

All FTM devices

FTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.

Indications for use as stated in the FDA summary.

Also cleared against K993459

2 other devices cite the same predicate.

  • K081272Porcine Surgical Mesh; Dermal MatrixBrennen Medical, LLC · 20084 recalls
  • K030460Modification to Brennen Biosynthetic Surgical Mesh MatrixBrennen Medical, Inc. · 2003

More from Carbon Medical Technologies, Inc.

38 FDA decisions under this applicant name. See the company

  • K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026
  • P980053/S021Durasphere Injectable Bulking AgentCarbon Medical Technologies, Inc. · 2026
  • K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc. · 2025
  • P980053/S020Durasphere® Injectable Bulking AgentCarbon Medical Technologies, Inc. · 2024
  • P980053/S019Durasphere Injectable Bulking AgentCarbon Medical Technologies, Inc. · 2022

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/K021160 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021160: Dermmatrix Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021160

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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