# K231163: HS Fiber Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Riverpoint Medical
- Decided: Jan 5, 2024 after 256 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: 7 generations back to K990088 (1999). 22 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190817: HS Fiber, Riverpoint Medical (2019) Summary page 4.

## Most influential descendants
- K253910: Stitch - Suture Wires and Tapes (2026), 0 descendants of its own
- K260775: Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™ (2026), 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/K231163
Methodology: https://510kreport.com/methodology