510(k) Report

510(k) · Cleared

Cleared

Star Temporary Wound Cover

K983753510(k) TraditionalCleared Nov 18, 1999398-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

Osteogenics, Inc. · FTL Mesh, Surgical, Polymeric

Cleared on Nov 18, 1999 after a 398-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it.

Decided
Nov 18, 1999
Review
398 days
Class
Class II
Product code
FTL
Recalls
None
Predicates
0

19 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2003: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2012: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2019: 4 descendants cleared2016: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK983753 Star Temporary Wound CoverOsteogenics, Inc. · 1999
  2. Descendant · cites it directly · 17 of its ownK022011 V.a.C. Abdominal DressingKinetic Concepts, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 11 of its ownK100787 Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc. · 2010
  4. Descendant · 3 generations on · 10 of its ownK112784 Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011
  5. Descendant · 4 generations on · 5 of its ownK143133 RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB…Smith & Nephew, Inc. · 2015
  6. Descendant · 5 generations on · 3 of its ownK181822 RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2003: 12006: 12009: 32010: 12011: 12012: 12013: 12014: 12015: 12016: 12019: 42022: 12024: 12026: 1
2003high 4 (2019) · low 0 (2004)2026

Most influential descendants

Showing 5 of 19 · See all
  • K022011V.a.C. Abdominal DressingKinetic Concepts, Inc. · 2003 · cites it directly17descendants
  • K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc. · 2010 · 2 generations on11descendants
  • K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc. · 2011 · 3 generations on10descendants
  • K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing…Smith & Nephew, Inc. · 2015 · 4 generations on5descendants
  • K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited · 2019 · 5 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983753Star Temporary Wound CoverOsteogenics, Inc.1999—
+1K022011V.a.C. Abdominal DressingKinetic Concepts, Inc.20031
+2K100787Renasys F/-AB Abdominal Wound Dressing KitSmith & Nephew, Inc.2010—
+3K112784Renasys AB Abominal Dressing KitSmith & Nephew, Inc.2011—
+4K143133RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal…Smith & Nephew, Inc.2015—
+5K181822RENASYS Touch; RENASYS Y-ConnectorSmith & Nephew Medical Limited2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200930
201010
201110
201210
201310
201410
201510
201610
201940
202210
202410
202610
FIG. 1 — Lineage of K983753, 1999–2026Source: 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 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?

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

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K022011V.a.C. Abdominal DressingKinetic Concepts, Inc.200317
K093166Wittmann PatchAperta, LLC20090

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, K022011 (Kinetic Concepts, Inc., 2003) has gone furthest, with 17 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?

For temporary bridging of abdominal wall openings where primary closure is not possible

and or repeat abdominal entries are 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 Osteogenics, Inc.

4 FDA decisions under this applicant name. See the company

  • K061934XTACOsteogenics, Inc. · 2007
  • K964537Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1997
  • K953339Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996

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https://510kreport.com/device/K983753 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983753: Star Temporary Wound Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983753

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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