# K252225: PowerKnot High Strength Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Sep 12, 2025 after 58 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071622: Arthrex Fiberwire, Arthrex, Inc. (2007) Summary page 5.

## Indications for use
PowerKnot High Strength Suture is indicated for soft tissue approximation and/or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Source page: https://510kreport.com/device/K252225
Methodology: https://510kreport.com/methodology