510(k) · Cleared
ClearedSTRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Mar 27, 2026 as substantially equivalent to K052373 (Quill Medical, Inc., 2005) and 1 other predicate after a 130-day review. Its family tree reaches back 12 generations to 2002.
- Decided
- Mar 27, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K014153 (2002). 35 ancestors in all, the oldest K885018 (1989). No later device cites it as a predicate yet.
- Root · 12 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 8 generations between
- 3 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 2 generations backK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- 1 generation backK151112 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Angiotech · 2015
- This deviceK253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control…ETHICON, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 11 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 10 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 9 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 8 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 7 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 6 generations backK072028 Quill Self-Retaining System (SRS) Comprised of MonodermSurgical Specialties Corp · 2007
- 5 generations backK100257 VLOC9ABSORBABLE Wound Closure DeviceSurgical Devices, A Division of Tyco Healthcare · 2010 · Recalled
- 4 generations backK122898 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012 · Recalled
- 3 generations backK123409 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 2 generations backK130078 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Surgical Specialties Corp. Dba Angiotech · 2013
- 1 generation backK151112 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop…Angiotech · 2015
- This deviceK253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control…ETHICON, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −11 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −10 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −9 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −8 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −7 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −6 | K072028 | Quill Self-Retaining System (SRS) Comprised of Monoderm | Surgical Specialties Corp | 2007 | — |
| −5 | K100257 | VLOC9ABSORBABLE Wound Closure Device | Surgical Devices, A Division of Tyco Healthcare | 2010 | 1 |
| −4 | K122898 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | 1 |
| −3 | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| −2 | K130078 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2013 | — |
| −1 | K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | Angiotech | 2015 | — |
| 0 (this device) | K253572 | STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device… | ETHICON, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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 GAW? 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 GAW device
- #1 K233355 Cypris eXact Suturing Systemscore 10.0 · 12 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 |
|---|---|---|---|
| * | K052373 | Quill Nonabsorbable Polypropylene Barbed SutureSummary page 5…y Marketed Predicate Devices 510(k) Number Product Code Primary Predicate Device: QUILL™ NONABSORBABLE POLYPROPYLENE K052373 GAW BARBED SUTURE (Bidirectional) Quill™ Polypropylene Knotless Tissue-Closure Device, K151112 GA… | 2005 |
| * | K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop DesignSummary page 5…NONABSORBABLE POLYPROPYLENE K052373 GAW BARBED SUTURE (Bidirectional) Quill™ Polypropylene Knotless Tissue-Closure Device, K151112 GAW Variable Loop Design (Unidirectional) Reference Predicate Devices (for Material): PRONOVA™ NONABSORBABLE SUTURE… | 2015 |
| † | K001625 | Pronova Nonabsorbable Suture, Usp | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 12 of the 35 ancestors have a recall of any class.
- 5 other devices also cite its predicate K052373.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device is indicated for use in soft tissue approximation where
the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.
The STRATAFIX™ Spiral PRONOVA™ Bidirectional Device is indicated for use in soft tissue approximation where the
use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253572: STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253572
Report an extraction error
Are you the manufacturer?
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