510(k) · Cleared
ClearedForce Fiber OrthoTape suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Apr 2, 2015 as substantially equivalent to K033654 (Teleflex Medical, 2004) and 3 other predicates after a 42-day review. Its family tree reaches back 5 generations to 1999. 14 later devices descend from it.
- Decided
- Apr 2, 2015
- Review
- 42 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K990088 (1999). 16 ancestors in all, the oldest K954808 (1996). 14 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 4 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 3 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 2 generations backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- 1 generation backK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
- This deviceK150438 Force Fiber OrthoTape sutureTeleflexmedical, Inc. · 2015
- Descendant · cites it directly · 10 of its ownK181774 Force Fiber White and White/Blue, White/Black, Blue, and White/Green…Teleflex Medical Incorporated · 2018
- Descendant · 2 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · 2 generations on · 2 of its ownK191268 Force Fiber SutureTeleflex Medical Incorporated · 2019
- Descendant · 3 generations on · 1 of its ownK242201 HyperSuture White/Green Extension LineThreadstone, LLC · 2025
- Descendant · 3 generations on · 1 of its ownK210675 EasyWhipWinter Innovations, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · cites it directly10descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 2 generations on4descendants
- K191268Force Fiber SutureTeleflex Medical Incorporated · 2019 · 2 generations on2descendants
- K242201HyperSuture White/Green Extension LineThreadstone, LLC · 2025 · 3 generations on1descendant
- K210675EasyWhipWinter Innovations, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −4 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −3 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −2 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| −1 | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures | Beere Precision Medical Instruments, Kmedic, Telef | 2009 | — |
| 0 (this device) | 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 | — |
| +2 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +2 | K191268 | Force Fiber Suture | Teleflex Medical Incorporated | 2019 | — |
| +3 | K242201 | HyperSuture White/Green Extension Line | Threadstone, LLC | 2025 | — |
| +3 | K210675 | EasyWhip | Winter Innovations, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K033654 | Force FiberSummary page 5…orce Fiber OrthoTape suture is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics The substa… | 2004 |
| * | K063778 | Force Fiber Polyethylene Nonabsorbable SutureSummary page 5…ture is substantially equivalent in intended use and fundamental scientific technology to the Force Fiber predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics The substantial equivalence of Fo… | 2007 |
| * | K092533 | Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesSummary page 5…equivalent in intended use and fundamental scientific technology to the Force Fiber predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics The substantial equivalence of Force Fiber OrthoTape su… | 2009 |
| * | K100506 | Force Fiber Green Ultra High Molecular Weight Polyethylene Non Absorbable Sutures…Summary page 5…and fundamental scientific technology to the Force Fiber predicate devices cleared under 510(k) #K033654 on 1/15/2004, K063778 on 2/09/2007, K092533 on 9/15/2009, and K100506 on 3/10/2010. Technological Characteristics The substantial equivalence of Force Fiber OrthoTape suture is supported by havin… | 2010 |
What descends from it? (14)
See all 144 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 16 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K181774 (Teleflex Medical Incorporated, 2018) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K033654.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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® OrthoTape™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150438: Force Fiber OrthoTape suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150438
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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