510(k) · Cleared
ClearedSteelex Sternum Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Dec 19, 2002 as substantially equivalent to K931271 (ETHICON, Inc., 1994) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 19, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931271 (1994). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 1 generation backK991073 Acier SuturesCardio Thoracic Systems · 1999
- This deviceK023411 Steelex Sternum SetAesculap, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK063603 Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15…Suturtek Incorporated · 2007
- Descendant · cites it directly · 1 of its ownK032468 Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003
- Descendant · 2 generations on · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009
- Descendant · 2 generations on · 0 of its ownK082828 Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated · 2008
Most influential descendants
Showing 4 of 4 · See all- K063603Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated · 2007 · cites it directly1descendant
- K032468Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003 · cites it directly1descendant
- K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009 · 2 generations on0descendants
- K082828Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| −1 | K991073 | Acier Sutures | Cardio Thoracic Systems | 1999 | — |
| 0 (this device) | K023411 | Steelex Sternum Set | Aesculap, Inc. | 2002 | — |
| +1 | K063603 | Suturtek Surgical Steel Suture, Models SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 | Suturtek Incorporated | 2007 | — |
| +1 | K032468 | Suturtek Fastclose Sternum Closure Device | Suturtek Incorporated | 2003 | — |
| +2 | K090686 | Sic Brevetti S.R.L. Device for Sternal Synthesis | Sic Brevetti S.R.L. | 2009 | — |
| +2 | K082828 | Suturtek 360 Degree Sternal Closure Device | Suturtek Incorporated | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (3)
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…BSTANTIAL EQUIVALENCE Aesculap@,Inc. believes that the Steelex Sternum Set is substantially equivalent to: 0 Ethicon, Inc. Ethi-Pack Surgical Stainless Steel Suture (K931271) 0 Stony Brook Surgical Innovations Sterna-Wire (KO13059) 0 CardioThoracic Systems, Inc. Acier Sutures (K991073) === Pag… | 1994 |
| * | K013059 | Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures) | 2001 |
| * | K991073 | Acier SuturesSummary page 1…, Inc. Ethi-Pack Surgical Stainless Steel Suture (K931271) 0 Stony Brook Surgical Innovations Sterna-Wire (KO13059) 0 CardioThoracic Systems, Inc. Acier Sutures (K991073) DEC 1 9 2092 Mr. Georg Keller Regblatory Affairs Manager… | 1999 |
What descends from it? (4)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K063603 (Suturtek Incorporated, 2007) has gone furthest, with 1 descendant of its own.
- 18 other devices also cite its predicate K931271.
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?
The Steelex Sternum Set is indicated in abdominal surgery, for orthopedic procedures (tendon operations and cerclages), hernia surgery and sternal closure. It is designed to remain inside the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023411: Steelex Sternum Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023411
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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