510(k) · Cleared
Recalled · Class II · 2016HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need
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 10, 2010 as substantially equivalent to K063778 (Teleflex Medical, 2007) and 4 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1999. 15 later devices descend from it. It has been recalled 2 times.
- Decided
- May 10, 2010
- Review
- 126 days
- Class
- Class II
- Product code
- GAT
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 4 generations to K990088 (1999). 19 ancestors in all, the oldest K930590 (1993). 15 later devices descend from it, 9 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 deviceK100006 HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro…Riverpoint Medical · 2010
- Descendant · cites it directly · 7 of its ownK153307 HS SutureTapeRiverpoint Medical · 2016
- Descendant · cites it directly · 6 of its ownK190817 HS FiberRiverpoint Medical · 2019
- Descendant · 2 generations on · 3 of its ownK231163 HS Fiber SuturesRiverpoint Medical · 2024
- Descendant · 3 generations on · 0 of its ownK253910 Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
- Descendant · 3 generations on · 0 of its ownK260775 Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K153307HS SutureTapeRiverpoint Medical · 2016 · cites it directly7descendants
- K190817HS FiberRiverpoint Medical · 2019 · cites it directly6descendants
- K231163HS Fiber SuturesRiverpoint Medical · 2024 · 2 generations on3descendants
- K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026 · 3 generations on0descendants
- K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026 · 3 generations on0descendants
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) | K100006 | HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene)… | Riverpoint Medical | 2010 | — |
| +1 | K153307 | HS SutureTape | Riverpoint Medical | 2016 | — |
| +1 | K190817 | HS Fiber | Riverpoint Medical | 2019 | — |
| +2 | K231163 | HS Fiber Sutures | Riverpoint Medical | 2024 | — |
| +3 | K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | 2026 | — |
| +3 | K260775 | Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ | Teleflex Medical, LLC | 2026 | — |
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 |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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? (5)
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 2…Alu: Class II (special controls); General and Plastic Surgery Predicate Devices (applicable 510(k) number listed) 1.Polyblend Suture: Teleflex® Force Fiber® (K063778) 2. Polyester Suture: Genzyme Biosurgery® (K021019) 3. Silk Suture: Sherwood-Davis & Geck® (K982853)… | 2007 |
| * | K021019 | Cottony II, Silky II Polydek & Tevdek II Polyester SutureSummary page 2…ry Predicate Devices (applicable 510(k) number listed) 1.Polyblend Suture: Teleflex® Force Fiber® (K063778) 2. Polyester Suture: Genzyme Biosurgery® (K021019) 3. Silk Suture: Sherwood-Davis & Geck® (K982853) 4. Polypropylene Suture: US Surgical® (K050947)… | 2002 |
| * | K982853 | Silk SutureSummary page 2….Polyblend Suture: Teleflex® Force Fiber® (K063778) 2. Polyester Suture: Genzyme Biosurgery® (K021019) 3. Silk Suture: Sherwood-Davis & Geck® (K982853) 4. Polypropylene Suture: US Surgical® (K050947) 5. Nylon Suture: CP Medical® (KOO1 173) Special C… | 1999 |
| * | K050947 | Modification to: Modified Uss Polypropylene SutureSummary page 2…2. Polyester Suture: Genzyme Biosurgery® (K021019) 3. Silk Suture: Sherwood-Davis & Geck® (K982853) 4. Polypropylene Suture: US Surgical® (K050947) 5. Nylon Suture: CP Medical® (KOO1 173) Special Controls FDA Guidance "Class 11Special Controls Gu… | 2005 |
| * | K001173 | Nylon, Nonabsorbable Surgical Sutures Usp | 2000 |
What descends from it? (15)
See all 159 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153307 | HS SutureTape | 2016 | 7 |
| K190817 | HS Fiber | 2019 | 6 |
| K232733 | Mbrace Cable | 2024 | 0 |
| K203408 | Summit Patella Plating System | 2021 | 0 |
| K202242 | HS Fiber | 2020 | 0 |
| K173644 | Gazelle Polypropylene Suture and Delivery Device | 2018 | 0 |
| K143582 | Mopylen, Resopren, Silk, Polyester, Nylon, Resolon, Polyamide Pseudo, Steel | 2015 | 0 |
| K152795 | RiverLon (Nylon) Suture | 2015 | 0 |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2016 | Class II | Z-2761-2016 | Nonconforming Material/Component | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
| Aug 5, 2016 | Class II | Z-2762-2016 | Nonconforming Material/Component | Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 8 of the 19 ancestors have a recall of any class.
- Of its descendants, K153307 (Riverpoint Medical, 2016) has gone furthest, with 7 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. 2010, 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?
RiverBond surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. RiverBond suture is provided sterile as a single use device. Hs Fiber surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures. HS Fiber suture is…
Read the full statement (171 words)
RiverBond surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
RiverBond suture is provided sterile as a single use device.
Hs Fiber surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
HS Fiber suture is provided sterile as a single use device.
RiverSilk surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
RiverSilk suture is provided sterile as a single use device.
RiverPro surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
RiverPro suture is provided sterile as a single use device.
Riverl-on and Riverton Braid surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
RiverPro suture is provided sterile as a single use device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100006
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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