# K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need

- Pathway: 510(k) (Abbreviated)
- Applicant: Riverpoint Medical
- Decided: May 10, 2010 after 126 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K990088 (1999). 19 ancestors in all.
15 later devices descend from it; 9 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063778: Force Fiber Polyethylene Nonabsorbable Suture, Teleflex Medical (2007) Summary page 2.
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture, Genzyme Corp. (2002) Summary page 2.
- K982853: Silk Suture, Davis & Geck, Inc. (1999) Summary page 2.
- K050947: Modification to: Modified Uss Polypropylene Suture, United States Surgical, A Division of Tyco Healthc (2005) Summary page 2.
- K001173: Nylon, Nonabsorbable Surgical Sutures Usp, Cp Medical (2000)

## Most influential descendants
- K153307: HS SutureTape (2016), 7 descendants of its own
- K190817: HS Fiber (2019), 6 descendants of its own
- K231163: HS Fiber Sutures (2024), 3 descendants of its own
- K253910: Stitch - Suture Wires and Tapes (2026), 0 descendants of its own
- K260775: Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (2026), 0 descendants of its own

## Recalls of this device
- Aug 5, 2016 · Class II · Z-2761-2016: Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
- Aug 5, 2016 · Class II · Z-2762-2016: Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.

## Indications for use
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.

Source page: https://510kreport.com/device/K100006
Methodology: https://510kreport.com/methodology