510(k) Report

510(k) · Cleared

Cleared

Biomerix Assure

K112567510(k) TraditionalCleared Dec 23, 2011112-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

Biomerix Corporation · FTL Mesh, Surgical, Polymeric

Cleared on Dec 23, 2011 as substantially equivalent to K093123 (Biomerix Corporation, 2010) and 3 other predicates after a 112-day review. Its family tree reaches back 11 generations to 1992.

Decided
Dec 23, 2011
Review
112 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
4

Its longest line of descent runs back 11 generations to K921895 (1992). 102 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors2002: 3 other ancestors2000: 10 other ancestors2007: 3 other ancestors2006: 3 other ancestors2005: 4 other ancestors2004: 10 other ancestors2003: 7 other ancestors2001: 7 other ancestors1997: 5 other ancestors1999: 3 other ancestors1998: 9 other ancestors1996: 8 other ancestors1992: 2 other ancestors1983: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1985: 1 other ancestor1993: 2 other ancestors1991: 4 other ancestors1990: 2 other ancestors1988: 1 other ancestor1989: 1 other ancestorK921895 · 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. · 2000K020049 · Fortaflex Surgical Mesh · Organogenesis, Inc. · 2002K042809 · Cuffpatch · Organogenesis, Inc. · 2004K052830 · Sportmesh · Artimplant AB · 2006K070961 · Biomerix Surgical Mesh, Model: RCR-01 · Biomerix Corporation · 2008K082941 · Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 · Biomerix Corporation · 2009K093123 · Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab · Biomerix Corporation · 20101980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 13 other ancestors3 generations back: 16 other ancestors4 generations back: 14 other ancestors5 generations back: 13 other ancestors6 generations back: 16 other ancestors7 generations back: 7 other ancestors8 generations back: 6 other ancestors9 generations back: 3 other ancestors K093123 · Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab · Biomerix Corporation · 2010K082941 · Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215 · Biomerix Corporation · 2009K070961 · Biomerix Surgical Mesh, Model: RCR-01 · Biomerix Corporation · 2008K052830 · Sportmesh · Artimplant AB · 2006K042809 · Cuffpatch · Organogenesis, Inc. · 2004K020049 · Fortaflex Surgical Mesh · Organogenesis, 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 · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 7 generations between
  3. 3 generations backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
  4. 2 generations backK082941 Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009
  5. 1 generation backK093123 Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010
  6. This deviceK112567 Biomerix AssureBiomerix Corporation · 2011
Show all 11 generations
  1. Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
  2. 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
  3. 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
  4. 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
  5. 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  6. 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  7. 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
  8. 4 generations backK052830 SportmeshArtimplant AB · 2006
  9. 3 generations backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
  10. 2 generations backK082941 Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009
  11. 1 generation backK093123 Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010
  12. This deviceK112567 Biomerix AssureBiomerix Corporation · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K921895Tissue Patch, Tissue GraftBio-Vascular, Inc.1992—
−10K961810Supple Peri-Guard PericardiumBio-Vascular, Inc.1996—
−9K980431SurgisisCook Biotech, Inc.1998—
−8K992159Surgisis SlingCook Biotech, Inc.1999—
−7K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
−6K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
−5K042809CuffpatchOrganogenesis, Inc.2004—
−4K052830SportmeshArtimplant AB2006—
−3K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation2008—
−2K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation2009—
−1K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation2010—
0 (this device)K112567Biomerix AssureBiomerix Corporation2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510
198810
198910
199020
199140
199220
199320
199420
199510
199680
199750
199890
199930
2000100
200170
200230
200370
2004100
200540
200630
200730
200820
FIG. 1 — Lineage of K112567, 1992–2011Source: 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? (4)

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
*K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab
Summary page 1
…ce Common Name: Polymeric surgical mesh Classification Name: Mesh, surgical, polymeric Predicate Devices: Biomerix Ventral Hernia Repair Mesh (K093123) Atrium Advanta PTFE Facial Implant (K992991) Tissue Sciences Laborator…
Biomerix Corporation2010—
*K992991Atrium Medical Corporation Advanta Ptfe Facial Implant
Summary page 1
…Mesh, surgical, polymeric Predicate Devices: Biomerix Ventral Hernia Repair Mesh (K093123) Atrium Advanta PTFE Facial Implant (K992991) Tissue Sciences Laboratories Permacol (K013625) Lifecell LTM-BPS Surgi…
Atrium Medical Corp.2000—
*K013625Permacol
Summary page 1
…ernia Repair Mesh (K093123) Atrium Advanta PTFE Facial Implant (K992991) Tissue Sciences Laboratories Permacol (K013625) Lifecell LTM-BPS Surgical Mesh (K0821 76) Device Description: Biomerix ASSURE is a sterile…
Tissue Science Laboratories, Plc2002—
*K082176LTM-BPS Surgical Mesh
Summary page 1
…a PTFE Facial Implant (K992991) Tissue Sciences Laboratories Permacol (K013625) Lifecell LTM-BPS Surgical Mesh (K0821 76) Device Description: Biomerix ASSURE is a sterile, composite mesh comprised of three layers…
Lifecell Corp.2008—

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 19 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
  • 12 of the 102 ancestors have a recall of any class.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

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?

Biomerix ASSURE TM is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.

Indications for use as stated in the FDA summary.

More from Biomerix Corporation

6 FDA decisions under this applicant name. See the company

  • K112499Biomerix Composite Surgical MeshBiomerix Corporation · 2011
  • K093123Biomerix Ventral Hernia Repair Mesh, Model SM3-TabBiomerix Corporation · 2010
  • K082941Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215Biomerix Corporation · 2009
  • K070961Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
  • K043371Biomerix Vascular Occlusion Device and LoaderBiomerix Corporation · 2005

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/K112567 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112567: Biomerix Assure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112567

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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