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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K252225

510(k) cleared

PowerKnot High Strength Sutures

Medacta International S.A. · Sep 12, 2025 · K252225

FDA cleared the PowerKnot High Strength Sutures from Medacta International S.A. on Sep 12, 2025 under K252225, a traditional 510(k). The device falls under product code GAT, Suture, Nonabsorbable, Synthetic, Polyethylene, regulated at 21 CFR 878.5000 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 16, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Medacta International S.A. has 8 other decisions in the tracker over the last 12 months: K261016 (MSS - Humeral reverse liners extension), K254202 (MectaLIF 3D Metal Anterior), K253940 (M.U.S.T. Pedicle Screw System - Extension), K253328 (GMK 3D Metal Tibial Tray Extension).

Questions & Answers

What did FDA clear under K252225?

K252225 is the FDA 510(k) for PowerKnot High Strength Sutures, submitted by Medacta International S.A.. FDA's decision date was Sep 12, 2025, under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene).

Who makes the PowerKnot High Strength Sutures?

Medacta International S.A., based in Castel San Pietro, is the applicant of record for K252225.

How long did the K252225 review take?

FDA received the submission on Jul 16, 2025 and issued its decision on Sep 12, 2025, 58 days later.

← All decisions in September 2025