510(k) · Cleared
ClearedSTRATAFIX Spiral PDS Plus Knotless Tissue Control Device
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 Jul 2, 2015 as substantially equivalent to K061037 (ETHICON, Inc., 2006) and 3 other predicates after a 108-day review. Its family tree reaches back 10 generations to 2002. 8 later devices descend from it.
- Decided
- Jul 2, 2015
- Review
- 108 days
- Class
- Class II
- Product code
- NEW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K014153 (2002). 28 ancestors in all, the oldest K915489 (1992). 8 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 6 generations between
- 3 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 2 generations backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- 1 generation backK120827 Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012
- This deviceK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
- 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 · 2 generations on · 1 of its ownK232246 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone)…M/s. Meril Endo Surgery Private Limited. · 2024
- Descendant · 2 generations on · 1 of its ownK192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 9 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 8 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 7 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 6 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 5 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 4 generations backK071989 Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical…Surgical Specialties Corp · 2007
- 3 generations backK080680 Quill Self-Retaining System (SRS) Comprised of Pdo (PolydioxanoneSurgical Specialties Corp · 2008
- 2 generations backK080985 Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo)Surgical Specialties Corp · 2008
- 1 generation backK120827 Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Angiotech · 2012
- This deviceK150670 STRATAFIX Spiral PDS Plus Knotless Tissue Control DeviceETHICON, Inc. · 2015
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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
- K2322461) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2)…M/s. Meril Endo Surgery Private Limited. · 2024 · 2 generations on1descendant
- K192144STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control DeviceETHICON, Inc. · 2020 · 2 generations on1descendant
- K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −9 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −8 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −7 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −6 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −5 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −4 | K071989 | Quill Self-Retaining System (SRS) Synthetic Absorbable Surgical Suture Material | Surgical Specialties Corp | 2007 | — |
| −3 | K080680 | Quill Self-Retaining System (SRS) Comprised of Pdo (Polydioxanone | Surgical Specialties Corp | 2008 | — |
| −2 | K080985 | Quill Self-Retaining System (SRS) Comprised of Polydioxanone (Pdo) | Surgical Specialties Corp | 2008 | — |
| −1 | K120827 | Quill Pdo Knotless Tissue-Closure Device (Polydixanone) | Angiotech | 2012 | — |
| 0 (this device) | K150670 | STRATAFIX Spiral PDS Plus Knotless Tissue Control Device | ETHICON, Inc. | 2015 | — |
| +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 | — |
| +2 | K232246 | 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless… | M/s. Meril Endo Surgery Private Limited. | 2024 | — |
| +2 | K192144 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device | ETHICON, Inc. | 2020 | 1 |
| +2 | K252047 | STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices | ETHICON, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K061037 | PDS Plus Antibacterial SutureSummary page 4…fication Name: Absorbable Polydioxanone Surgical Suture (21 CFR 878.4840) Product Code: NEW Predicate Device 510(k) Number PDS™ Plus Antibacterial (polydioxanone) Suture K061037 Quill™ PDO Knotless Tissue Closure Device, Variable K123877 : K113744 Loop (polydioxanone) - Quill™ PDO Knotless Tissue Closure D… | 2006 |
| * | K123877 | Quill Pdo Knotless Tissue-Closure Device, Variable Loop DesignSummary page 4…CFR 878.4840) Product Code: NEW Predicate Device 510(k) Number PDS™ Plus Antibacterial (polydioxanone) Suture K061037 Quill™ PDO Knotless Tissue Closure Device, Variable K123877 : K113744 Loop (polydioxanone) - Quill™ PDO Knotless Tissue Closure Device K120827 Page 17 K150670 Page 2 of 3… | 2013 |
| * | K113744 | Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)Summary page 4…40) Product Code: NEW Predicate Device 510(k) Number PDS™ Plus Antibacterial (polydioxanone) Suture K061037 Quill™ PDO Knotless Tissue Closure Device, Variable K123877 : K113744 Loop (polydioxanone) - Quill™ PDO Knotless Tissue Closure Device K120827 Page 17 K150670 Page 2 of 3 Traditiona… | 2012 |
| * | K120827 | Quill Pdo Knotless Tissue-Closure Device (Polydixanone)Summary page 4…ial (polydioxanone) Suture K061037 Quill™ PDO Knotless Tissue Closure Device, Variable K123877 : K113744 Loop (polydioxanone) - Quill™ PDO Knotless Tissue Closure Device K120827 Page 17 K150670 Page 2 of 3 Traditional 510(k) STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Conirol Device Ethic… | 2012 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182873 | STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus… | 2019 | 7 |
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?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 10 of the 28 ancestors have a recall of any class.
- Of its descendants, K182873 (ETHICON, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K061037.
How does its category compare?
All NEW devicesNEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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™ Spiral PDS™ Plus Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
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/K150670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150670: STRATAFIX Spiral PDS Plus Knotless Tissue Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150670
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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