510(k) · Cleared
ClearedGynecare Prolene Fastener System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Cleared on Dec 22, 2004 after an 89-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Dec 22, 2004
- Review
- 89 days
- Class
- Class II
- Product code
- PBQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK042603 Gynecare Prolene Fastener SystemETHICON, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK120831 AnchorsureNeomedic International S.L. · 2012
- Descendant · 2 generations on · 3 of its ownK160569 NeuGuidePop Medical Solutions · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK213783 ApyxEscala Medical · 2022
- Descendant · 4 generations on · 1 of its ownK230730 ApyxEscala Medical · 2023
- Descendant · 5 generations on · 0 of its ownK260380 MenditEscala Medical, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120831AnchorsureNeomedic International S.L. · 2012 · cites it directly5descendants
- K160569NeuGuidePop Medical Solutions · 2016 · 2 generations on3descendants
- K213783ApyxEscala Medical · 2022 · 3 generations on2descendants
- K230730ApyxEscala Medical · 2023 · 4 generations on1descendant
- K260380MenditEscala Medical, Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042603 | Gynecare Prolene Fastener System | ETHICON, Inc. | 2004 | — |
| +1 | K120831 | Anchorsure | Neomedic International S.L. | 2012 | — |
| +2 | K160569 | NeuGuide | Pop Medical Solutions | 2016 | 1 |
| +3 | K213783 | Apyx | Escala Medical | 2022 | — |
| +4 | K230730 | Apyx | Escala Medical | 2023 | — |
| +5 | K260380 | Mendit | Escala Medical, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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 PBQ? 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 PBQ device
- #1 K260380 Menditscore 12.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ETHIBOND EXCEL suture Named without a submission number | |
| * | — | ETHICON PROLENE suture Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120831 | Anchorsure | 2012 | 5 |
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, K120831 (Neomedic International S.L., 2012) has gone furthest, with 5 descendants of its own.
How does its category compare?
All PBQ devicesPBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PBQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBQ
Too few PBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBQ
5in 2025
MAUDE reports naming product code PBQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, non-woven surgical mesh and suture to ligaments of the pelvic floor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K042603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042603: Gynecare Prolene Fastener System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042603
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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