# K252201: HS Fiber

- Pathway: 510(k) (Special)
- Applicant: Riverpoint Medical
- Decided: Aug 13, 2025 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: 8 generations back to K990088 (1999). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231163: HS Fiber Sutures, Riverpoint Medical (2024) Summary page 5.

## Indications for use
The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.

Source page: https://510kreport.com/device/K252201
Methodology: https://510kreport.com/methodology