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THE TAPE

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 / January 2026 / K260004

510(k) cleared

Aevumed PROTEKT Suture Anchor

Aevumed, Inc. · Jan 28, 2026 · K260004

FDA cleared the Aevumed PROTEKT Suture Anchor from Aevumed, Inc. on Jan 28, 2026 under K260004, a special 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 Jan 2, 2026. The decision came 26 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: K254306 (Aevumed FENIX Suture Anchor), K253040 (Aevumed FASE Suture Anchor).

Questions & Answers

What did FDA clear under K260004?

K260004 is the FDA 510(k) for Aevumed PROTEKT Suture Anchor, submitted by Aevumed, Inc.. FDA's decision date was Jan 28, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Aevumed PROTEKT Suture Anchor?

Aevumed, Inc., based in Malvern, PA, is the applicant of record for K260004.

How long did the K260004 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Jan 28, 2026, 26 days later.

← All decisions in January 2026

Sources