510(k) · Cleared
Recalled · Class II · 2026Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Jan 9, 1995 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 155 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 9, 1995
- Review
- 21 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- 10
- Predicates
- 0
155 later devices descend from it, 19 citing it directly.
- This deviceK946173 Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide…ETHICON, Inc. · 1995
- Descendant · cites it directly · 85 of its ownK110789 Synthes Sternal Zipfix SystemSynthes (Usa) · 2011 · Recalled
- Descendant · cites it directly · 78 of its ownK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
- Descendant · 2 generations on · 75 of its ownK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
- Descendant · cites it directly · 46 of its ownK122293 Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
- Descendant · 2 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
Showing 5 of 155 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 155 · See all- K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 2011 · cites it directly85descendants
- K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · cites it directly78descendants
- K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012 · 2 generations on75descendants
- K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012 · cites it directly46descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 2 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene… | ETHICON, Inc. | 1995 | — |
| +1 | K110789 | Synthes Sternal Zipfix System | Synthes (Usa) | 2011 | 3 |
| +1 | K111908 | Biomet Microfixation Sternal Closure System | Biomet Microfixation, Inc. | 2011 | — |
| +2 | K121302 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2012 | — |
| +1 | K122293 | Pioneer Sternal Cable Plate System | Pioneer Surgical Technology, Inc. | 2012 | — |
| +2 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 11 | 0 |
| 2023 | 11 | 0 |
| 2024 | 16 | 0 |
| 2025 | 16 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAQ? 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 GAQ device
- #1 K203855 CoNextions TR Tendon Repair Systemscore 3.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (155)
See all 15519 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110789 | Synthes Sternal Zipfix System | 2011 | 85 |
| K111908 | Biomet Microfixation Sternal Closure System | 2011 | 78 |
| K122293 | Pioneer Sternal Cable Plate System | 2012 | 46 |
| K133785 | Tritium Sternal Cable Plate System | 2014 | 45 |
| K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | 2017 | 42 |
| K023125 | Coalescent U-Clip- and Accessories | 2002 | 42 |
| K101484 | Compressyn Band | 2011 | 5 |
| K133356 | Prolene Polypropylene Nonabsorbable Suture | 2013 | 4 |
| K142484 | Sternal Closure System | 2014 | 1 |
| K110039 | Biomet Sports Medicine Sternal Closure System | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2026 | Not classified | Z-0284-2027 | Process control | Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or… |
| Sep 8, 2026 | Class II | Z-0153-2027 | Process control | Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause… |
| Mar 7, 2025 | Class II | Z-1516-2025 | Process control | Identified curing issues with the silicone during the needles manufacturing process. |
| Dec 20, 2024 | Class II | Z-1097-2025 | Process control | Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection. |
| Jun 10, 2020 | Class II | Z-2486-2020 | Nonconforming Material/Component | Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years |
| Apr 19, 2019 | Class II | Z-1842-2019 | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot |
| Apr 19, 2019 | Class II | Z-1841-2019 | Material/Component Contamination | Possibility that a suture raw material containing high endotoxin levels was used in the manufacturing of this lot |
| Dec 18, 2018 | Class II | Z-0747-2019 | Packaging process control | The sutures inside the packaging are not the same size or type as indicated on the label. |
| May 8, 2015 | Class II | Z-1839-2015 | Labeling mix-ups | Ethicon Fast Absorbing Surgical Gut (Plain) Suture is being recalled because the labeling on the box and foil are incomplete. |
| Oct 17, 2014 | Class II | Z-0492-2015 | Other | Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110789 (Synthes (Usa), 2011) has gone furthest, with 85 descendants of its own.
How does its category compare?
All GAQ devicesGAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · GAQ
Too few GAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GAQ
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAQ
83in 2025
MAUDE reports naming product code GAQ, 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 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 19 |
| 2012 | 0 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 2 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 17 |
| 2016 | 0 | — | 0 | 23 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 0 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 52 |
| 2021 | 0 | — | 0 | 39 |
| 2022 | 1 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 100 |
| 2024 | 0 | — | 0 | 176 |
| 2025 | 0 | — | 0 | 83 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K946173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946173
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026