510(k) · Cleared
ClearedForce Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical Incorporated · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Oct 10, 2018 as substantially equivalent to K063778 (Teleflex Medical, 2007) and 8 other predicates after a 99-day review. Its family tree reaches back 6 generations to 1999. 10 later devices descend from it.
- Decided
- Oct 10, 2018
- Review
- 99 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 6 generations to K990088 (1999). 36 ancestors in all, the oldest K885018 (1989). 10 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 5 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 4 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 3 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- 2 generations backK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
- 1 generation backK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
- This deviceK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- Descendant · cites it directly · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · cites it directly · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
- Descendant · 2 generations on · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
- Descendant · 2 generations on · 1 of its ownK210675 EasyWhipWinter Innovations, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK261988 Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic…Teleflex Medical, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K230311HyperSutureThreadstone, LLC · 2023 · cites it directly4descendants
- K191268Force Fiber SutureTeleflex Medical Incorporated · 2019 · cites it directly2descendants
- K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025 · 2 generations on1descendant
- K210675EasyWhipWinter Innovations, Inc. · 2021 · 2 generations on1descendant
- K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −5 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −4 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −3 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| −2 | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | Beere Precision Medical Instruments, Kmedic, Telef | 2009 | — |
| −1 | K150438 | Force Fiber OrthoTape suture | Teleflexmedical, Inc. | 2015 | — |
| 0 (this device) | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +1 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +1 | K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019 | — |
| +2 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025 | — |
| +2 | K210675 | EasyWhip | Winter Innovations, Inc. | 2021 | — |
| +1 | K261988 | Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable… | Teleflex Medical, LLC | 2026 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 K230311 HyperSuturescore 20.2 · 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? (9)
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 |
|---|---|---|---|
| * | K063778 | Force Fiber Polyethylene Nonabsorbable SutureSummary page 11…Manufacturer 510(k) No. Date Cleared Force Fiber White and White Blue Co-Braid Teleflex Medical K063778 2/09/2007 Polyethylene Non-Absorbable Surgical Suture Force Fiber Black Co-Braid Polyethylene Non-… | 2007 |
| * | K070673 | Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureSummary page 11…07 Polyethylene Non-Absorbable Surgical Suture Force Fiber Black Co-Braid Polyethylene Non- Teleflex Medical K070673 4/2/2007 Absorbable Surgical Suture Force Fiber Blue Ultra High Molecular Weight… | 2007 |
| * | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesSummary page 11…0673 4/2/2007 Absorbable Surgical Suture Force Fiber Blue Ultra High Molecular Weight Teleflex Medical K092533 9/15/2009 Polyethylene Non Absorbable Sutures Force Fiber Green Ultra High Molecular Weight… | 2009 |
| * | K100506 | Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures…Summary page 11…9/15/2009 Polyethylene Non Absorbable Sutures Force Fiber Green Ultra High Molecular Weight Teleflex Medical K100506 3/10/2010 Polyethylene Non Absorbable Sutures Force Fiber OrthoTape Suture Teleflex Medical K1… | 2010 |
| * | K150438 | Force Fiber OrthoTape sutureSummary page 11…Teleflex Medical K100506 3/10/2010 Polyethylene Non Absorbable Sutures Force Fiber OrthoTape Suture Teleflex Medical K150438 04/02/2015 Bondek Polyglycolic Acid Synthetic Teleflex Medical K9… | 2015 |
| * | K991191 | Bondek Polyglycolic Acid Synthetic Absorbable Surgical SutureSummary page 11…Teleflex Medical K150438 04/02/2015 Bondek Polyglycolic Acid Synthetic Teleflex Medical K991191 06/22/1999 Absorbable Surgical Suture Bondek Plus Polyglycolic Acid Synthetic… | 1999 |
| * | K992088 | Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureSummary page 11…Bondek Plus Polyglycolic Acid Synthetic 09/03/1999 Teleflex Medical K992088 Absorbable Surgical Suture Monodek Synthetic Absorbable Surgical Suture Teleflex Medical K030212 03/27/2003… | 1999 |
| * | K030212 | Monodek Synthetic Absorbable Surgical SutureSummary page 11…Teleflex Medical K992088 Absorbable Surgical Suture Monodek Synthetic Absorbable Surgical Suture Teleflex Medical K030212 03/27/2003 Polyglytone 6211 Synthetic Absorbable Suture Teleflex Medical K042141 09/28/2004 === Page 12 ==… | 2003 |
| * | K042141 | Polyglytone 6211 Synthetic Absorbable SutureSummary page 11…Monodek Synthetic Absorbable Surgical Suture Teleflex Medical K030212 03/27/2003 Polyglytone 6211 Synthetic Absorbable Suture Teleflex Medical K042141 09/28/2004 K181774, Page 5 of 5… | 2004 |
What descends from it? (10)
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 19 years and passes through 6 companies; a new generation was cleared every 3.5 years on median.
- 15 of the 36 ancestors have a recall of any class.
- Of its descendants, K230311 (Threadstone, LLC, 2023) has gone furthest, with 4 descendants of its own.
- 16 other devices also cite its predicate K063778.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries. Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for…
Read the full statement (185 words)
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.
Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181774
Report an extraction error
Are you the manufacturer?
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