510(k) · Cleared
ClearedEthi-Pack* Surgical Stainless Steel Suture
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 7, 1994 after a 305-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 114 later devices descend from it.
- Decided
- Jan 7, 1994
- Review
- 305 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 0
114 later devices descend from it, 19 citing it directly.
- This deviceK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 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 · 62 of its ownK051165 KLS Martin Sternal TalonKLS-Martin L.P. · 2006
- Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 114 · 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
- K051165KLS Martin Sternal TalonKLS-Martin L.P. · 2006 · cites it directly62descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| +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 | K051165 | KLS Martin Sternal Talon | KLS-Martin L.P. | 2006 | — |
| +2 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 10 | 0 |
| 2023 | 8 | 0 |
| 2024 | 16 | 0 |
| 2025 | 15 | 0 |
| 2026 | 13 | 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? (114)
See all 11419 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 |
| K051165 | KLS Martin Sternal Talon | 2006 | 62 |
| K151983 | KLS Martin LSS Plating System | 2016 | 45 |
| K991073 | Acier Sutures | 1999 | 11 |
| K013059 | Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures) | 2001 | 7 |
| K101484 | Compressyn Band | 2011 | 5 |
| K023594 | Teno Fix | 2003 | 5 |
| K023411 | Steelex Sternum Set | 2002 | 4 |
| K173579 | Thorecon™ Fixation System | 2018 | 1 |
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, 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/K931271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K931271: Ethi-Pack* Surgical Stainless Steel Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931271
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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