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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 / March 2026 / K254306

510(k) cleared

Aevumed FENIX Suture Anchor

Aevumed, Inc. · Mar 4, 2026 · K254306

FDA cleared the Aevumed FENIX Suture Anchor from Aevumed, Inc. on Mar 4, 2026 under K254306, a traditional 510(k). The device falls under product code MBI, Fastener, Fixation, Nondegradable, Soft Tissue, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 31, 2025. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Aevumed, Inc. has 2 other decisions in the tracker over the last 12 months: K260004 (Aevumed PROTEKT Suture Anchor), K253040 (Aevumed FASE Suture Anchor).

Questions & Answers

What did FDA clear under K254306?

K254306 is the FDA 510(k) for Aevumed FENIX Suture Anchor, submitted by Aevumed, Inc.. FDA's decision date was Mar 4, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Aevumed FENIX Suture Anchor?

Aevumed, Inc., based in Malvern, PA, is the applicant of record for K254306.

How long did the K254306 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Mar 4, 2026, 63 days later.

← All decisions in March 2026

Sources