510(k) · Cleared
Recalled · Class II · 2022STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Aug 13, 2015 as substantially equivalent to K050845 (ETHICON, Inc., 2005) and 3 other predicates after a 100-day review. Its family tree reaches back 12 generations to 2002. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 13, 2015
- Review
- 100 days
- Class
- Class II
- Product code
- GAM
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 12 generations to K014153 (2002). 36 ancestors in all, the oldest K885018 (1989). 8 later devices descend from it, 2 citing it directly.
- 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 backK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
- This deviceK151200 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX…ETHICON, 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 · cites it directly · 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 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 backK123836 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corp. Dba Angiotech · 2012
- 1 generation backK141778 Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSurgical Specialties Corporation · 2014
- This deviceK151200 STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX…ETHICON, 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 · cites it directly1descendant
- 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 |
|---|---|---|---|---|---|
| −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 | K123836 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corp. Dba Angiotech | 2012 | — |
| −1 | K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop Design | Surgical Specialties Corporation | 2014 | — |
| 0 (this device) | K151200 | STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral… | 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 | — |
| +1 | 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 |
|---|---|---|
| 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 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 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 GAM? 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 GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 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 |
|---|---|---|---|
| * | K050845 | Monocryl Plus Antibacterial SutureSummary page 4…icate Device 510(k) Number MONOCRYL™ Plus Antibacterial (poliglecaprone 25) Suture K050845 Quill™ MONODERM™ Knotless Tissue Closure Device, Variable K141778 Loop Design… | 2005 |
| * | K141778 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 4…ONOCRYL™ Plus Antibacterial (poliglecaprone 25) Suture K050845 Quill™ MONODERM™ Knotless Tissue Closure Device, Variable K141778 Loop Design K123836… | 2014 |
| * | K123836 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 4…uill™ MONODERM™ Knotless Tissue Closure Device, Variable K141778 Loop Design K123836 K123409… | 2012 |
| * | K123409 | Quill Monoderm Knotless Tissue-Closure Device, Variable Loop DesignSummary page 4…oop Design K123836 K123409 K151200 Traditional 51… | 2012 |
What descends from it? (8)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2022 | Class II | Z-0150-2023 | Under Investigation by firm | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 14 of the 36 ancestors have a recall of any class.
- Of its descendants, K182873 (ETHICON, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K050845.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, 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 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device are indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151200 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151200: STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus 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/K151200
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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