510(k) · Cleared
ClearedForce Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical 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, 2007 as substantially equivalent to K063778 (Teleflex Medical, 2007) and 1 other predicate after a 21-day review. Its family tree reaches back 4 generations to 1999. 23 later devices descend from it.
- Decided
- Apr 2, 2007
- Review
- 21 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K990088 (1999). 15 ancestors in all, the oldest K930738 (1994). 23 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
- 3 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
- 2 generations backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
- 1 generation backK063778 Force Fiber Polyethylene Nonabsorbable SutureTeleflex Medical · 2007 · Recalled
- This deviceK070673 Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical SutureTeleflexmedical, Inc. · 2007
- 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 · cites it directly · 7 of its ownK132867 Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture…Cayenne Medical, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK151068 SureLock W Suture AnchorCayenne Medical, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK230311 HyperSutureThreadstone, LLC · 2023
- Descendant · 3 generations on · 4 of its ownK172186 BioWick X Implant with DriverCayenne Medical, Inc. · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K181774Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force…Teleflex Medical Incorporated · 2018 · cites it directly10descendants
- K132867Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…Cayenne Medical, Inc. · 2013 · cites it directly7descendants
- K151068SureLock W Suture AnchorCayenne Medical, Inc. · 2015 · 2 generations on6descendants
- K230311HyperSutureThreadstone, LLC · 2023 · 2 generations on4descendants
- K172186BioWick X Implant with DriverCayenne Medical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990088 | Synthofil Nonabsorbable Pet Surgical Suture | Aesculap, Inc. | 1999 | — |
| −3 | K012923 | Arthrex Fiberwire, Usp Size 5, Model AR-7201 | Arthrex, Inc. | 2001 | — |
| −2 | K021434 | Arthrex Fiberwire in Usp Sizes | Arthrex, Inc. | 2002 | — |
| −1 | K063778 | Force Fiber Polyethylene Nonabsorbable Suture | Teleflex Medical | 2007 | 1 |
| 0 (this device) | K070673 | Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture | Teleflexmedical, Inc. | 2007 | — |
| +1 | K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures… | Teleflex Medical Incorporated | 2018 | — |
| +1 | K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor… | Cayenne Medical, Inc. | 2013 | — |
| +2 | K151068 | SureLock W Suture Anchor | Cayenne Medical, Inc. | 2015 | — |
| +2 | K230311 | HyperSuture | Threadstone, LLC | 2023 | — |
| +3 | K172186 | BioWick X Implant with Driver | Cayenne Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 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? (2)
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 1…valence The device is the same intended use and fundamental scientific technology as Teleflex Medical Force Fiber®t Polyethylene Non-absorbable Surgical Suture (K063778); and the same fundamental scientific technology as the Teleflex Medical Nylon Polyamide Non- absorbable Surgical Suture… | 2007 |
| * | K930738 | Surgical Sutures, PGL, Gut, Deklene, Opthamend EtcSummary page 1…Non-absorbable Surgical Suture (K063778); and the same fundamental scientific technology as the Teleflex Medical Nylon Polyamide Non- absorbable Surgical Suture (K93073 8). Teleflex Medical Nylon Polyamnide Non-absorbable CONFIDENTIAL 15… | 1994 |
What descends from it? (23)
See all 237 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181774 | Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force… | 2018 | 10 |
| K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with… | 2013 | 7 |
| K191268 | Force Fiber Suture | 2019 | 2 |
| K172016 | Force Fiber Fusion Suture | 2017 | 1 |
| K112960 | Labralink Suture Anchor with Inserter, 2.9MM Per-Loaded with One (1) and (2) #2 Uhmwpe… | 2012 | 1 |
| K131325 | Quattro GL Suture Anchor | 2013 | 0 |
| K112814 | Cuffink | 2012 | 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?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K181774 (Teleflex Medical Incorporated, 2018) has gone furthest, with 10 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. 2007, 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® Black Co-Braid Polyethylene 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 orthopaedic surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070673: Force Fiber Black CO-Braid Polyethylene Non-Absorbable Surgical Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070673
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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