# K190817: HS Fiber

- Pathway: 510(k) (Special)
- Applicant: Riverpoint Medical
- Decided: May 1, 2019 after 30 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990088 (1999). 21 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need, Riverpoint Medical (2010) Summary page 4.
- K153307: HS SutureTape, Riverpoint Medical (2016) Summary page 4.

## Most influential descendants
- 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
- K253024: ProZip Knotless Implant (2025), 0 descendants of its own
- K252201: HS Fiber (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K190817
Methodology: https://510kreport.com/methodology