510(k) · Cleared
ClearedSuturtek 360 Degree Sternal Closure Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suturtek Incorporated · GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Cleared on Oct 14, 2008 as substantially equivalent to K032468 (Suturtek Incorporated, 2003) after a 19-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 14, 2008
- Review
- 19 days
- Class
- Class II
- Product code
- GAQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K931271 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK931271 Ethi-Pack* Surgical Stainless Steel SutureETHICON, Inc. · 1994
- 3 generations backK991073 Acier SuturesCardio Thoracic Systems · 1999
- 2 generations backK023411 Steelex Sternum SetAesculap, Inc. · 2002
- 1 generation backK032468 Suturtek Fastclose Sternum Closure DeviceSuturtek Incorporated · 2003
- This deviceK082828 Suturtek 360 Degree Sternal Closure DeviceSuturtek Incorporated · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931271 | Ethi-Pack* Surgical Stainless Steel Suture | ETHICON, Inc. | 1994 | — |
| −3 | K991073 | Acier Sutures | Cardio Thoracic Systems | 1999 | — |
| −2 | K023411 | Steelex Sternum Set | Aesculap, Inc. | 2002 | — |
| −1 | K032468 | Suturtek Fastclose Sternum Closure Device | Suturtek Incorporated | 2003 | — |
| 0 (this device) | K082828 | Suturtek 360 Degree Sternal Closure Device | Suturtek Incorporated | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K032468 | Suturtek Fastclose Sternum Closure DeviceSummary page 1…Multifilament 3. Identification of Predicate or Legally Marketed Device SuturTek FASTCLOSE'Fm Sternum Closure DeviceTm K032468 4. Device Description and Operation The SuturTek 360 ° Sternal Closure DeviceTM is a an instrument… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- None of the 7 ancestors has a recall.
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. 2008, 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?
The Suturtek 3600 Sternal Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needle stick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082828: Suturtek 360 Degree Sternal Closure Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082828
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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