510(k) · Cleared
ClearedAcier Sutures
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardio Thoracic Systems · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Jul 30, 1999 as substantially equivalent to K931271 (ETHICON, Inc., 1994) after a 121-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Jul 30, 1999
- Review
- 121 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931271 (1994). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- This deviceK991073 Acier SuturesCardio Thoracic Systems · 1999
- Descendant · cites it directly · 5 of its ownK023594 Teno FixOrtheon Medical, LLC · 2003
- Descendant · cites it directly · 4 of its ownK023411 Steelex Sternum SetAesculap, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK101126 Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010
- Descendant · 3 generations on · 1 of its ownK140127 Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK063603 Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15…Suturtek Incorporated · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K023594Teno FixOrtheon Medical, LLC · 2003 · cites it directly5descendants
- K023411Steelex Sternum SetAesculap, Inc. · 2002 · cites it directly4descendants
- K101126Pontis Sutures and Suture Anchors with Optional CrimpsCore Essence Orthopaedics, Inc. · 2010 · 2 generations on3descendants
- K140127Ferrofibre Stainless Steel Suture with CrimpPontis Orthopaedics, LLC · 2014 · 3 generations on1descendant
- K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated · 2007 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| 0 (this device) | K991073 | Acier Sutures | Cardio Thoracic Systems | 1999 | — |
| +1 | K023594 | Teno Fix | Ortheon Medical, LLC | 2003 | — |
| +1 | K023411 | Steelex Sternum Set | Aesculap, Inc. | 2002 | — |
| +2 | K101126 | Pontis Sutures and Suture Anchors with Optional Crimps | Core Essence Orthopaedics, Inc. | 2010 | — |
| +3 | K140127 | Ferrofibre Stainless Steel Suture with Crimp | Pontis Orthopaedics, LLC | 2014 | — |
| +2 | K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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 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? (1)
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 |
|---|---|---|---|
| * | K931271 | Ethi-Pack* Surgical Stainless Steel SutureSummary page 1…ament and Multifilament Surgical Suture Trade Name: Acier Generic/Common Name: Surgical Sutures PREDICATE DEVICES Ethicon’s Ethi-Pack Surgical Stainless Steel Suture; K931271 INTENDED USE Acier Steel Suture is indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, and ster… | 1994 |
What descends from it? (11)
See all 112 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.
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?
Acier Surgical Suture is indicated for use in abdominal wound closure, hernia repair, sternal closure, and certain orthopedic 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/K991073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991073: Acier Sutures.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991073
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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