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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 / January 2026 / K253763

510(k) cleared

Y-Knotless Flex Anchors

Conmed Corporation · Jan 29, 2026 · K253763

FDA cleared the Y-Knotless Flex Anchors from Conmed Corporation on Jan 29, 2026 under K253763, 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 Nov 25, 2025. The decision came 65 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: K261363 (Y-Knotless Flex Anchors), K252946 (BioBrace® Extra-Articular Ligament Augmentation Kit).

Questions & Answers

What did FDA clear under K253763?

K253763 is the FDA 510(k) for Y-Knotless Flex Anchors, submitted by Conmed Corporation. FDA's decision date was Jan 29, 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 K253763.

How long did the K253763 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Jan 29, 2026, 65 days later.

← All decisions in January 2026

Sources