510(k) Report

510(k) · Cleared

Cleared

Sterile Suprafoil Smooth Nylon Foil Sheets

K973379510(k) TraditionalCleared Sep 25, 199717-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. · FTM Mesh, Surgical

Cleared on Sep 25, 1997 after a 17-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 106 later devices descend from it.

Decided
Sep 25, 1997
Review
17 days
Class
Class II
Product code
FTM
Recalls
None
Predicates
0

106 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 6 descendants cleared2007: 5 descendants cleared2002: 1 descendant cleared2005: 1 descendant cleared2011: 8 descendants cleared2004: 1 descendant cleared2006: 2 descendants cleared2023: 4 descendants cleared2009: 5 descendants cleared2019: 4 descendants cleared2017: 8 descendants cleared2016: 10 descendants cleared2015: 4 descendants cleared2010: 4 descendants cleared2014: 6 descendants cleared2013: 7 descendants cleared2012: 4 descendants cleared2022: 5 descendants cleared2024: 4 descendants cleared2018: 2 descendants cleared2021: 2 descendants cleared2025: 10 descendants cleared2026: 3 descendants clearedReference device: K831725 · Foil in 3 Forms-Non-Sterile Sheets · S. Jackson, Inc. · 19831995200020052010201520202025
  1. This deviceK973379 Sterile Suprafoil Smooth Nylon Foil SheetsS. Jackson, Inc. · 1997
  2. Descendant · cites it directly · 95 of its ownK013625 PermacolTissue Science Laboratories, Plc · 2002
  3. Descendant · 2 generations on · 93 of its ownK034039 Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004
  4. Descendant · 3 generations on · 50 of its ownK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
  5. Descendant · 2 generations on · 18 of its ownK060829 CosmatrixTei Biosciences, Inc. · 2006
  6. Descendant · 3 generations on · 17 of its ownK071807 Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · Recalled

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 12006: 22007: 52008: 62009: 52010: 42011: 82012: 42013: 72014: 62015: 42016: 102017: 82018: 22019: 42021: 22022: 52023: 42024: 42025: 102026: 3
2002high 10 (2016) · low 0 (2003)2026

Most influential descendants

Showing 5 of 106 · See all
  • K013625PermacolTissue Science Laboratories, Plc · 2002 · cites it directly95descendants
  • K034039Sis Plastic Surgery MatrixCook Biotech, Inc. · 2004 · 2 generations on93descendants
  • K070560LRTM Surgical MeshLifecell Corp. · 2007 · 3 generations on50descendants
  • K060829CosmatrixTei Biosciences, Inc. · 2006 · 2 generations on18descendants
  • K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc. · 2007 · 3 generations on17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K973379Sterile Suprafoil Smooth Nylon Foil SheetsS. Jackson, Inc.1997—
+1K013625PermacolTissue Science Laboratories, Plc2002—
+2K034039Sis Plastic Surgery MatrixCook Biotech, Inc.2004—
+3K070560LRTM Surgical MeshLifecell Corp.20072
+2K060829CosmatrixTei Biosciences, Inc.2006—
+3K071807Orthomend Soft Tissue MatrixTei Biosciences, Inc.20074

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
200620
200750
200860
200950
201040
201180
201240
201370
201460
201540
2016100
201780
201820
201940
202120
202250
202340
202440
2025100
202630
FIG. 1 — Lineage of K973379, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (106)

See all 106

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

NumberDeviceApplicantDecidedDescendants
K013625PermacolTissue Science Laboratories, Plc200295
K063648Surgi-Wrap Mast Tendon SheetMast Biosurgery USA, Inc.200712
K072190Ortho-Wrap Bioresorbable SheetMast Biosurgery200810

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?

  • Of its descendants, K013625 (Tissue Science Laboratories, Plc, 2002) has gone furthest, with 95 descendants of its own.

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?

The Foil is intended for use by surgeons only where indicated for plastic and reconstructive surgery. The most widespread and standard use presently is for repair of orbital floor blow-out fractures in the eye. Its use is detailed in articles by Orkan Stasior, M.D., Merrill J. Reeh and James Tsujimura, M.D., J. Emery, M.D., G. von Noorden, M.D., and Donald Schlernitzauer, M.D. The foil is also used in Tympanoplasty in the middle ear as reference…

Read the full statement (136 words)

The Foil is intended for use by surgeons only where indicated for plastic and reconstructive surgery. The most widespread and standard use presently is for repair of orbital floor blow-out fractures in the eye. Its use is detailed in articles by Orkan Stasior, M.D., Merrill J. Reeh and James Tsujimura, M.D., J. Emery, M.D., G. von Noorden, M.D., and Donald Schlernitzauer, M.D. The foil is also used in Tympanoplasty in the middle ear as reference in...(the) article by James L. Sheehy, M.D. It has also been used to separate nerves and tendons from surrounding tissue to prevent adhesions during healing and then removed after healing is complete. It has been used to repair or replace dura matter in the skull, and in heavier thicknesses it has been attched to bones to give added strength where necessary.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from S. Jackson, Inc.

30 FDA decisions under this applicant name. See the company

  • K080216Supramesh ExtraS. Jackson, Inc. · 2008
  • K931613Supramid SutureS. Jackson, Inc. · 1993
  • K931612Nylamid SutureS. Jackson, Inc. · 1993
  • K931614Mopylen SutureS. Jackson, Inc. · 1993
  • K922630MopylenS. Jackson, Inc. · 1992

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https://510kreport.com/device/K973379 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973379: Sterile Suprafoil Smooth Nylon Foil Sheets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973379

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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