510(k) Report

510(k) · Cleared

Cleared

Sis Hernia Repair Device

K974540510(k) TraditionalCleared May 20, 1998168-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

Sentron Medical, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on May 20, 1998 after a 168-day review. The FDA summary names no predicate by number. 180 later devices descend from it.

Decided
May 20, 1998
Review
168 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

180 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared1998: 1 descendant cleared2014: 8 descendants cleared2002: 4 descendants cleared2012: 9 descendants cleared2006: 7 descendants cleared2003: 3 descendants cleared2008: 8 descendants cleared2005: 3 descendants cleared2018: 9 descendants cleared2004: 3 descendants cleared2010: 9 descendants cleared2009: 11 descendants cleared2007: 8 descendants cleared2017: 12 descendants cleared2015: 5 descendants cleared2013: 6 descendants cleared2016: 7 descendants cleared2025: 10 descendants cleared2021: 5 descendants cleared2011: 9 descendants cleared2019: 5 descendants cleared2023: 6 descendants cleared2026: 10 descendants cleared2022: 7 descendants cleared2024: 12 descendants cleared2020: 2 descendants cleared1995200020052010201520202025
  1. This deviceK974540 Sis Hernia Repair DeviceSentron Medical, Inc. · 1998
  2. Descendant · cites it directly · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
  3. Descendant · 2 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
  4. Descendant · cites it directly · 92 of its ownK982330 Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998
  5. Descendant · 2 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
  6. Descendant · 3 generations on · 72 of its ownK042809 CuffpatchOrganogenesis, Inc. · 2004

Showing 5 of 180 descendants. See all descendants

Descendants cleared per year

1998: 12000: 12002: 42003: 32004: 32005: 32006: 72007: 82008: 82009: 112010: 92011: 92012: 92013: 62014: 82015: 52016: 72017: 122018: 92019: 52020: 22021: 52022: 72023: 62024: 122025: 102026: 10
1998high 12 (2017) · low 0 (1999)2026

Most influential descendants

Showing 5 of 180 · See all
  • K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · cites it directly173descendants
  • K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 2 generations on102descendants
  • K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc. · 1998 · cites it directly92descendants
  • K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 2 generations on91descendants
  • K042809CuffpatchOrganogenesis, Inc. · 2004 · 3 generations on72descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974540Sis Hernia Repair DeviceSentron Medical, Inc.1998—
+1K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000—
+2K020049Fortaflex Surgical MeshOrganogenesis, Inc.2002—
+1K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.1998—
+2K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2003—
+3K042809CuffpatchOrganogenesis, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200240
200330
200430
200530
200670
200780
200880
2009110
201090
201190
201290
201360
201480
201550
201670
2017120
201890
201950
202020
202150
202270
202360
2024120
2025100
2026100
FIG. 1 — Lineage of K974540, 1998–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (180)

See all 180

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

NumberDeviceApplicantDecidedDescendants
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc.2000173
K982330Depuy Orthotech Restore Orthobiologic Soft Tissue ImplantDepuy, Inc.199892
K133011Diaphragmatic Hernia GraftCook Biotech, Inc.20141
K133306Sis Hernia GraftCook Biotech, Inc.20140
K111695Hybrid GraftCook Biotech, Inc.20120
K020654Stratasis Sling KitCook Biotech, Inc.20020

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, K001738 (DePuy Orthopaedics, Inc., 2000) has gone furthest, with 173 descendants 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.

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?

The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in FTL

The FTL category page

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https://510kreport.com/device/K974540 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974540: Sis Hernia Repair Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974540

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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