510(k) · Cleared
ClearedHS Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Riverpoint Medical · GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Cleared on May 1, 2019 as substantially equivalent to K100006 (Riverpoint Medical, 2010) and 1 other predicate after a 30-day review. Its family tree reaches back 6 generations to 1999. 6 later devices descend from it.
- Decided
- May 1, 2019
- Review
- 30 days
- Class
- Class II
- Product code
- GAT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K990088 (1999). 21 ancestors in all, the oldest K930590 (1993). 6 later devices descend from it, 3 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 backK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010 · Recalled
- 1 generation backK153307 HS SutureTapeRiverpoint Medical · 2016
- This deviceK190817 HS FiberRiverpoint Medical · 2019
- Descendant · cites it directly · 3 of its ownK231163 HS Fiber SuturesRiverpoint Medical · 2024
- Descendant · 2 generations on · 0 of its ownK253910 Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 2 generations on · 0 of its ownK260775 Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK253024 ProZip Knotless ImplantRiverpoint Medical · 2025
- Descendant · 2 generations on · 0 of its ownK252201 HS FiberRiverpoint Medical · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231163HS Fiber SuturesRiverpoint Medical · 2024 · cites it directly3descendants
- K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026 · 2 generations on0descendants
- K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026 · 2 generations on0descendants
- K253024ProZip Knotless ImplantRiverpoint Medical · 2025 · cites it directly0descendants
- K252201HS FiberRiverpoint Medical · 2025 · 2 generations on0descendants
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 | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)… | Riverpoint Medical | 2010 | 2 |
| −1 | K153307 | HS SutureTape | Riverpoint Medical | 2016 | — |
| 0 (this device) | K190817 | HS Fiber | Riverpoint Medical | 2019 | — |
| +1 | K231163 | HS Fiber Sutures | Riverpoint Medical | 2024 | — |
| +2 | K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +2 | K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026 | — |
| +1 | K253024 | ProZip Knotless Implant | Riverpoint Medical | 2025 | — |
| +2 | K252201 | HS Fiber | Riverpoint Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon…Summary page 4…Division of Surgical Devices, Plastic and Reconstructive General Surgery Devices Branch Predicate Device K100006 – Riverpoint Medical HS Fiber (Polyblend) K153307 – HS Fiber SutureTape… | 2010 |
| * | K153307 | HS SutureTapeSummary page 4…evices, Plastic and Reconstructive General Surgery Devices Branch Predicate Device K100006 – Riverpoint Medical HS Fiber (Polyblend) K153307 – HS Fiber SutureTape K190817 Pa… | 2016 |
What descends from it? (6)
3 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 20 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 9 of the 21 ancestors have a recall of any class.
- Of its descendants, K231163 (Riverpoint Medical, 2024) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K100006.
How does its category compare?
All GAT devicesGAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular
surgery, and the use of allograft tissues for orthopedic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190817: HS Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190817
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