510(k) · Cleared
ClearedForce Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on Jan 15, 2004 after a 55-day review. The FDA summary names no predicate by number. 89 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 55 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 0
89 later devices descend from it, 7 citing it directly.
- This deviceK033654 Force FiberTeleflex Medical · 2004
- Descendant · cites it directly · 69 of its ownK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- Descendant · 2 generations on · 29 of its ownK092533 Force Fiber Blue Ultra High Molecular Weight Polyethylene Non…Beere Precision Medical Instruments, Kmedic, Telef · 2009
- Descendant · 2 generations on · 23 of its ownK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
- Descendant · cites it directly · 16 of its ownK041216 Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004
- Descendant · 2 generations on · 15 of its ownK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K063778Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · cites it directly69descendants
- K092533Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable SuturesBeere Precision Medical Instruments, Kmedic, Telef · 2009 · 2 generations on29descendants
- K070673Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007 · 2 generations on23descendants
- K041216Smith & Nephew Ultrabraid SutureSmith & Nephew, Inc. · 2004 · cites it directly16descendants
- K100006HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Riverpoint Medical · 2010 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033654 | Force Fiber | Teleflex Medical | 2004 | — |
| +1 | 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 | — |
| +2 | K070673 | Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture | Teleflexmedical, Inc. | 2007 | — |
| +1 | K041216 | Smith & Nephew Ultrabraid Suture | Smith & Nephew, Inc. | 2004 | — |
| +2 | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)… | Riverpoint Medical | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 12 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 7 | 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?
The FDA summary names no predicate by number.
What descends from it? (89)
See all 897 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063778 | Force Fiber Polyethylene Nonabsorbable Suture | 2007 | 69 |
| K041216 | Smith & Nephew Ultrabraid Suture | 2004 | 16 |
| K150438 | Force Fiber OrthoTape suture | 2015 | 14 |
| K191268 | Force Fiber Suture | 2019 | 2 |
| K150584 | Stryker Suture Tape | 2015 | 2 |
| K151009 | Nexus Suture | 2015 | 0 |
| K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) | 2007 | 0 |
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?
- Of its descendants, K063778 (Teleflex Medical, 2007) has gone furthest, with 69 descendants of its own.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 FiberTM Polyethylene Nonabsorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033654 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033654: Force Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033654
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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