510(k) · Cleared
ClearedSurgical Stainless Steel Suture, 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 Nov 1, 2017 as substantially equivalent to K946173 (ETHICON, Inc., 1995) after a 232-day review. Its family tree reaches back 1 generation to 1995. 42 later devices descend from it.
- Decided
- Nov 1, 2017
- Review
- 232 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946173 (1995). 42 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK946173 Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide…ETHICON, Inc. · 1995 · Recalled
- This deviceK170767 Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc. · 2017
- Descendant · cites it directly · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
- Descendant · 2 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 3 generations on · 13 of its ownK222973 IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous…Alphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 8 of its ownK232432 E3D™-A Interbody SystemEvolution Spine · 2024
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · cites it directly39descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 2 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
- K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc. · 2022 · 3 generations on13descendants
- K232432E3D™-A Interbody SystemEvolution Spine · 2024 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene… | ETHICON, Inc. | 1995 | 10 |
| 0 (this device) | K170767 | Surgical Stainless Steel Suture, Stainless Steel Suture | ETHICON, Inc. | 2017 | — |
| +1 | K202889 | Able Medical Devices Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices | 2021 | — |
| +2 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +3 | K222973 | IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti… | Alphatec Spine, Inc. | 2022 | — |
| +3 | K232432 | E3D™-A Interbody System | Evolution Spine | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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 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? (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 |
|---|---|---|---|
| * | K946173 | Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…Summary page 4…Sterile Regulation Number: 21 CFR 878.4495 Regulatory Class: II Product Code: GAQ • Surgical Stainless Steel Suture; K946173, cleared January 9, 1995; Labeling Changes for Generic Suture Types, by Ethicon, Inc., Predicate Devic… | 1995 |
| * | — | Surgical Stainless Steel Suture Named without a submission number |
What descends from it? (42)
See all 423 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2017, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Stainless Steel Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure and orthopaedic procedures including cerclage and tendon repair.
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/K170767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170767: Surgical Stainless Steel Suture, Stainless Steel Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170767
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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