510(k) Report

510(k) · Cleared

Cleared

Tyrx Surgical Mesh, Model SMPC-0501

K052864510(k) TraditionalCleared Dec 22, 200572-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

Tyrx Pharma, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Dec 22, 2005 as substantially equivalent to K002672 (ETHICON, Inc., 2000) and 2 other predicates after a 72-day review. Its family tree reaches back 2 generations to 2000. 25 later devices descend from it.

Decided
Dec 22, 2005
Review
72 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K001122 (2000). 5 ancestors in all, the oldest K962530 (1996). 25 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1996: 1 other ancestor2006: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2008: 1 descendant cleared2013: 3 descendants cleared2014: 3 descendants cleared2022: 1 descendant cleared2018: 3 descendants cleared2015: 3 descendants cleared2016: 1 descendant cleared2017: 1 descendant cleared2020: 3 descendants cleared2019: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK001122 · Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh · ETHICON, Inc. · 2000K043081 · Gore Polypropylene Hernia Mesh · W. L. Gore & Associates, Inc. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 4 descendants6 generations forward: 3 descendants7 generations forward: 3 descendants K043081 · Gore Polypropylene Hernia Mesh · W. L. Gore & Associates, Inc. · 2004K001122 · Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh · ETHICON, Inc. · 20000+5
  1. Root · 2 generations backK001122 Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshETHICON, Inc. · 2000
  2. 1 generation backK043081 Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc. · 2004
  3. This deviceK052864 Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc. · 2005
  4. Descendant · cites it directly · 24 of its ownK053656 Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006
  5. Descendant · 2 generations on · 17 of its ownK063091 Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · Recalled
  6. Descendant · 3 generations on · 14 of its ownK130943 Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013
  7. Descendant · 3 generations on · 6 of its ownK131007 Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013
  8. Descendant · 4 generations on · 5 of its ownK132699 Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12010: 12012: 12013: 32014: 32015: 32016: 12017: 12018: 32019: 12020: 32022: 12024: 12026: 1
2006high 3 (2013) · low 0 (2007)2026

Most influential descendants

Showing 5 of 25 · See all
  • K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006 · cites it directly24descendants
  • K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 2008 · 2 generations on17descendants
  • K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc. · 2013 · 3 generations on14descendants
  • K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc. · 2013 · 3 generations on6descendants
  • K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc. · 2013 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001122Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshETHICON, Inc.2000—
−1K043081Gore Polypropylene Hernia MeshW. L. Gore & Associates, Inc.2004—
0 (this device)K052864Tyrx Surgical Mesh, Model SMPC-0501Tyrx Pharma, Inc.2005—
+1K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.2006—
+2K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc.20083
+3K130943Aigis RX R PM/ Aigis RX R IcdTyrx, Inc.2013—
+3K131007Aigis RX N Medium; Aigis RX N LargeTyrx, Inc.2013—
+4K132699Aigis RX N (Medium), Aigis RX N (Large)Tyrx, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201010
201210
201330
201430
201530
201610
201710
201830
201910
202030
202210
202410
202610
FIG. 1 — Lineage of K052864, 2000–2026Source: 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 FTL? 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 FTL device

  1. #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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
*K002672Vypro Mesh, Vicryl Prolene Partially Absorbable Synthetic Surgical Mesh
Summary page 1
…Common/Classification Name: Polymeric Surgical Mesh Predicate Devices Name2 and 5 10(k) Numbers: VYPRO Mesh VICRYL-PROLENE partially absorbable synthetic surgical mesh (K002672) PROLENE polypropylene mesh nonabsorbable synthetic mesh (K962530) GORE POLYPROPYLENE HERNIA Mesh (K043081) Device Description:…
ETHICON, Inc.2000—
*K962530Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh
Summary page 1
…ices Name2 and 5 10(k) Numbers: VYPRO Mesh VICRYL-PROLENE partially absorbable synthetic surgical mesh (K002672) PROLENE polypropylene mesh nonabsorbable synthetic mesh (K962530) GORE POLYPROPYLENE HERNIA Mesh (K043081) Device Description: TyRx Surgical Mesh is dual component (resorbable and non-resorbabl…
ETHICON, Inc.1996—
*K043081Gore Polypropylene Hernia Mesh
Summary page 1
…h VICRYL-PROLENE partially absorbable synthetic surgical mesh (K002672) PROLENE polypropylene mesh nonabsorbable synthetic mesh (K962530) GORE POLYPROPYLENE HERNIA Mesh (K043081) Device Description: TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the r…
W. L. Gore & Associates, Inc.2004—

Also cleared against K002672: 1 other device →

What descends from it? (25)

See all 25

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc.200624

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 5 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K053656 (Tyrx Pharma, Inc., 2006) has gone furthest, with 24 descendants of its own.
  • 1 other device also cites its predicate K002672.

How does its category compare?

All FTL devices

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

FDA decisions per year · FTL

6in 2025

2007: 202008: 232009: 152010: 182011: 152012: 122013: 82014: 112015: 122016: 32017: 62018: 122019: 42020: 52021: 22022: 62023: 42024: 22025: 62026 (partial year): 2
2007high 23 (2008) · low 2 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTL

30in 2025

2007: 92 days median2008: 114 days median2009: 97 days median2010: 132 days median2011: 90 days median2012: 213 days median2013: 90 days median2014: 70 days median2015: 121 days median2016: 186 days median2017: 132 days median2018: 105 days median2019: 99 days median2020: 138 days median2022: 195 days median2023: 29 days median2025: 30 days median
2007high 213 (2012) · low 29 (2023)2026

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

Recalls per year · FTL

1in 2020

2007: 22008: 12009: 12010: 122011: 82012: 22013: 12014: 32017: 12018: 12020: 1
2007high 12 (2010) · low 0 (2015)2026

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

Adverse event reports per year · FTL

3,487in 2025

2007: 1,7372008: 1,5692009: 1,9062010: 2,1752011: 3,6082012: 14,7002013: 26,5192014: 2,6832015: 2,5262016: 2,4172017: 3,9472018: 11,8932019: 21,7242020: 18,8192021: 16,2842022: 11,4392023: 8,0252024: 8,5652025: 3,487
2007high 26,519 (2013) · low 1,569 (2008)2025

MAUDE reports naming product code FTL, 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
2007209221,737
20082311411,569
2009159711,906
201018132122,175
2011159083,608
201212213214,700
2013890126,519
2014117032,683
20151212102,526
2016318602,417
2017613213,947
201812105111,893
2019499021,724
20205138118,819
20212—016,284
20226195011,439
202342908,025
20242—08,565
202563003,487
20262—0—

What is it indicated for?

Is intended for the repair of hernias and other abdominal fascial deficiencies requitling the addition of a reinforcing or bridging material to obtain the desired surgical result.. Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

Indications for use as stated in the FDA summary.

Also cleared against K002672

1 other device cites the same predicate.

  • K053424PopmeshCaldera Medical, Inc. · 2006

More from Tyrx Pharma, Inc.

3 FDA decisions under this applicant name. See the company

  • K063091Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601Tyrx Pharma, Inc. · 20083 recalls
  • K053656Tyrx Antimicrobial MeshTyrx Pharma, Inc. · 2006

Recent decisions in FTL

The FTL category page

  • K260474Liora Monofilament ScaffoldTELA Bio, Inc. · 2026
  • K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production · 2026
  • K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production · 2025
  • K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
  • K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc. · 2025

https://510kreport.com/device/K052864 · printed Nov 4, 2026

Cite this page

510(k) Report. “K052864: Tyrx Surgical Mesh, Model SMPC-0501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052864

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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