510(k) Report

510(k) · Cleared

Cleared

Supramesh Extra

K080216510(k) TraditionalCleared Sep 15, 2008230-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

S. Jackson, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Sep 15, 2008 as substantially equivalent to K831723 (S. Jackson, Inc., 1983) and 2 other predicates after a 230-day review. Its family tree reaches back 1 generation to 1983. 2 later devices descend from it.

Decided
Sep 15, 2008
Review
230 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K831723 (1983). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1985: 1 other ancestor1983: 1 other ancestor2009: 1 descendant cleared2010: 1 descendant clearedK831723 · Supramid Extra Surgical Mesh · S. Jackson, Inc. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K831723 · Supramid Extra Surgical Mesh · S. Jackson, Inc. · 19830
  1. Root · 1 generation backK831723 Supramid Extra Surgical MeshS. Jackson, Inc. · 1983
  2. This deviceK080216 Supramesh ExtraS. Jackson, Inc. · 2008
  3. Descendant · cites it directly · 1 of its ownK083102 Refine Lift SystemAlure Medical, Inc. · 2009
  4. Descendant · 2 generations on · 0 of its ownK092538 Refine Support System, Model 100.0100Alure Medical, Inc. · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K083102Refine Lift SystemAlure Medical, Inc. · 2009 · cites it directly1descendant
  • K092538Refine Support System, Model 100.0100Alure Medical, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K831723Supramid Extra Surgical MeshS. Jackson, Inc.1983—
0 (this device)K080216Supramesh ExtraS. Jackson, Inc.2008—
+1K083102Refine Lift SystemAlure Medical, Inc.2009—
+2K092538Refine Support System, Model 100.0100Alure Medical, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
FIG. 1 — Lineage of K080216, 1983–2010Source: 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
*K831723Supramid Extra Surgical Mesh
Summary page 2
…1 x 1 Tricot stitch mesh. S. Jackson, Inc. currently manufactures Supramid Extra Surgical Mesh (marketed as SupraMESH®) sterile mesh sheets under FDA K831723, K852011 and K831724. SupraMESH EXTRA TM nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (mark…
S. Jackson, Inc.1983—
*K852011Nylamid Mesh Pad Full & Half
Summary page 2
…icot stitch mesh. S. Jackson, Inc. currently manufactures Supramid Extra Surgical Mesh (marketed as SupraMESH®) sterile mesh sheets under FDA K831723, K852011 and K831724. SupraMESH EXTRA TM nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (marketed as S…
S. Jackson, Inc.1985—
*K831724Chin (Mentoplasty) Implants
Summary page 2
…mesh. S. Jackson, Inc. currently manufactures Supramid Extra Surgical Mesh (marketed as SupraMESH®) sterile mesh sheets under FDA K831723, K852011 and K831724. SupraMESH EXTRA TM nylon mesh is substantially equivalent to Supramid Extra Surgical Mesh (marketed as SupraMESH®) F…
S. Jackson, Inc.1983—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K083102Refine Lift SystemAlure Medical, Inc.20091

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K083102 (Alure Medical, Inc., 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FTL devices

FTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?

SupraMESH EXTRATM nylon mesh is indicated for use as a hernia mesh and for plastic and reconstructive surgery.

Indications for use as stated in the FDA summary.

More from S. Jackson, Inc.

30 FDA decisions under this applicant name. See the company

  • K973379Sterile Suprafoil Smooth Nylon Foil SheetsS. Jackson, Inc. · 1997
  • K931613Supramid SutureS. Jackson, Inc. · 1993
  • K931612Nylamid SutureS. Jackson, Inc. · 1993
  • K931614Mopylen SutureS. Jackson, Inc. · 1993
  • K922630MopylenS. Jackson, Inc. · 1992

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/K080216 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080216: Supramesh Extra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080216

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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