510(k) K252225

PowerKnot High Strength Sutures by Medacta International S.A. — Product Code GAT

K252225 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "PowerKnot High Strength Sutures". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Medacta International S.A. has at least 10 other 510(k) clearances on record.