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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 / May 2026 / K261363

510(k) cleared

Y-Knotless Flex Anchors

CONMED Corporation · May 13, 2026 · K261363

FDA cleared the Y-Knotless Flex Anchors from CONMED Corporation on May 13, 2026 under K261363, 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 Apr 27, 2026. The decision came 16 days later, inside the 90 FDA-day goal for a 510(k).

CONMED Corporation has 2 other decisions in the tracker over the last 12 months: K253763 (Y-Knotless Flex Anchors), K252946 (BioBrace® Extra-Articular Ligament Augmentation Kit).

Questions & Answers

What did FDA clear under K261363?

K261363 is the FDA 510(k) for Y-Knotless Flex Anchors, submitted by CONMED Corporation. FDA's decision date was May 13, 2026, under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

Who makes the Y-Knotless Flex Anchors?

CONMED Corporation, based in Utica, NY, is the applicant of record for K261363.

How long did the K261363 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on May 13, 2026, 16 days later.

← All decisions in May 2026

Sources