510(k) · Decided
DecidedStratafix Symmetric PDS Plus Knotless Tissue Control Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · NEW Suture, Surgical, Absorbable, Polydioxanone
Cleared on Oct 15, 2014 after a 105-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Oct 15, 2014
- Review
- 105 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK141776 Stratafix Symmetric PDS Plus Knotless Tissue Control DevicesETHICON, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK182873 STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices…ETHICON, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 2 of its ownK221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK150553 FilblocAssut Europe · 2016
- Descendant · 2 generations on · 1 of its ownK242835 Suture-TOOL SystemSuturion AB · 2025
- Descendant · 2 generations on · 1 of its ownK232246 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone)…M/s. Meril Endo Surgery Private Limited. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K182873STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus…ETHICON, Inc. · 2019 · cites it directly7descendants
- K221744STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control DeviceETHICON, Inc. · 2022 · 2 generations on2descendants
- K150553FilblocAssut Europe · 2016 · cites it directly2descendants
- K242835Suture-TOOL SystemSuturion AB · 2025 · 2 generations on1descendant
- K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited. · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141776 | Stratafix Symmetric PDS Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2014 | — |
| +1 | K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral… | ETHICON, Inc. | 2019 | 5 |
| +2 | K221744 | STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device | ETHICON, Inc. | 2022 | — |
| +1 | K150553 | Filbloc | Assut Europe | 2016 | — |
| +2 | K242835 | Suture-TOOL System | Suturion AB | 2025 | — |
| +2 | K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless… | M/s. Meril Endo Surgery Private Limited. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 NEW? 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 NEW device
- #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Named without a submission number |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K182873 (ETHICON, Inc., 2019) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NEW
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEW
146in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEW
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEW
2,504in 2025
MAUDE reports naming product code NEW, 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 | 2 | — | 0 | 7 |
| 2008 | 5 | 22 | 1 | 29 |
| 2009 | 0 | — | 4 | 42 |
| 2010 | 3 | 270 | 0 | 115 |
| 2011 | 1 | — | 0 | 59 |
| 2012 | 3 | 113 | 1 | 82 |
| 2013 | 5 | 32 | 1 | 185 |
| 2014 | 1 | — | 1 | 274 |
| 2015 | 2 | — | 0 | 280 |
| 2016 | 3 | 254 | 0 | 321 |
| 2017 | 1 | — | 0 | 461 |
| 2018 | 3 | 441 | 0 | 900 |
| 2019 | 4 | 144 | 2 | 1,122 |
| 2020 | 3 | 230 | 0 | 1,010 |
| 2021 | 1 | — | 0 | 1,466 |
| 2022 | 1 | — | 1 | 1,537 |
| 2023 | 1 | — | 0 | 1,975 |
| 2024 | 3 | 48 | 0 | 2,114 |
| 2025 | 6 | 146 | 0 | 2,504 |
| 2026 | 5 | 264 | 0 | — |
What is it indicated for?
STRATAFIX™ Symmetric PDS™ Plus Devices are indicated for general soft tissue approximation where use of an absorbable suture is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141776 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141776: Stratafix Symmetric PDS Plus Knotless Tissue Control Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141776
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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