510(k) · Cleared
ClearedHyperSuture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Threadstone, LLC · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Nov 24, 2023 as substantially equivalent to K181774 (Teleflex Medical Incorporated, 2018) after a 294-day review. Its family tree reaches back 7 generations to 1999. 4 later devices descend from it.
- Decided
- Nov 24, 2023
- Review
- 294 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K990088 (1999). 37 ancestors in all, the oldest K885018 (1989). 4 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 6 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 5 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 4 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- 3 generations backK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
- 2 generations backK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
- 1 generation backK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- This deviceK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · cites it directly · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
- Descendant · cites it directly · 0 of its ownK254275 HyperSuture All Green Extension LineThreadstone, LLC · 2026
- Descendant · cites it directly · 0 of its ownK241376 HyperSuture All Blue Extension LineThreadstone, LLC · 2024
- Descendant · cites it directly · 0 of its ownK234079 HyperSuture Extension LineThreadstone, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025 · cites it directly1descendant
- K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026 · cites it directly0descendants
- K241376HyperSuture All Blue Extension LineThreadstone, LLC · 2024 · cites it directly0descendants
- K234079HyperSuture Extension LineThreadstone, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −6 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −5 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −4 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| −3 | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | Beere Precision Medical Instruments, Kmedic, Telef | 2009 | — |
| −2 | K150438 | Force Fiber OrthoTape suture | Teleflexmedical, Inc. | 2015 | — |
| −1 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| 0 (this device) | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +1 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025 | — |
| +1 | K254275 | HyperSuture All Green Extension Line | Threadstone, LLC | 2026 | — |
| +1 | K241376 | HyperSuture All Blue Extension Line | Threadstone, LLC | 2024 | — |
| +1 | K234079 | HyperSuture Extension Line | Threadstone, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 GAT? 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 GAT device
- #1 K231163 HS Fiber Suturesscore 17.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Summary page 5…Division of Surgical Devices, Plastic and Reconstructive General Surgery Devices Branch 4. Predicate Device K181774 – Force Fiber Suture and Force Fiber OrthoTape Suture… | 2018 |
What descends from it? (4)
4 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 24 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 15 of the 37 ancestors have a recall of any class.
- Of its descendants, K242201 (Threadstone, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K181774.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GAT
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAT
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAT
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAT
2,956in 2025
MAUDE reports naming product code GAT, 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 | 6 | 40 | 1 | 15 |
| 2008 | 4 | 93 | 0 | 15 |
| 2009 | 9 | 57 | 0 | 55 |
| 2010 | 11 | 27 | 3 | 79 |
| 2011 | 1 | — | 1 | 97 |
| 2012 | 6 | 61 | 0 | 253 |
| 2013 | 4 | 123 | 0 | 210 |
| 2014 | 4 | 45 | 0 | 165 |
| 2015 | 7 | 125 | 0 | 626 |
| 2016 | 10 | 139 | 0 | 688 |
| 2017 | 6 | 57 | 0 | 1,104 |
| 2018 | 6 | 95 | 0 | 1,453 |
| 2019 | 4 | 79 | 0 | 1,251 |
| 2020 | 5 | 201 | 0 | 1,220 |
| 2021 | 4 | 92 | 0 | 1,643 |
| 2022 | 5 | 109 | 0 | 1,419 |
| 2023 | 8 | 220 | 0 | 2,038 |
| 2024 | 3 | 140 | 0 | 2,597 |
| 2025 | 5 | 30 | 0 | 2,956 |
| 2026 | 5 | 83 | 0 | — |
What is it indicated for?
HyperSuture sutures (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230311 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230311: HyperSuture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230311
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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