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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 / October 2025 / K252946

510(k) cleared

BioBrace® Extra-Articular Ligament Augmentation Kit

Conmed Corporation · Oct 15, 2025 · K252946

FDA cleared the BioBrace® Extra-Articular Ligament Augmentation Kit from Conmed Corporation on Oct 15, 2025 under K252946, a special 510(k). The device falls under product code MAI, Fastener, Fixation, Biodegradable, Soft Tissue, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 15, 2025. The decision came 30 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), K253763 (Y-Knotless Flex Anchors).

Questions & Answers

What did FDA clear under K252946?

K252946 is the FDA 510(k) for BioBrace® Extra-Articular Ligament Augmentation Kit, submitted by Conmed Corporation. FDA's decision date was Oct 15, 2025, under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue).

Who makes the BioBrace® Extra-Articular Ligament Augmentation Kit?

Conmed Corporation, based in Utica, NY, is the applicant of record for K252946.

How long did the K252946 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Oct 15, 2025, 30 days later.

← All decisions in October 2025

Sources