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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 / November 2025 / K252666

510(k) cleared

Articulator Arthroscopic Bur

Joint Preservation Innovations, LLC · Nov 21, 2025 · K252666

FDA cleared the Articulator Arthroscopic Bur from Joint Preservation Innovations, LLC on Nov 21, 2025 under K252666, a traditional 510(k). The device falls under product code HRX, Arthroscope, regulated at 21 CFR 888.1100 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Aug 25, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Joint Preservation Innovations, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252666?

K252666 is the FDA 510(k) for Articulator Arthroscopic Bur, submitted by Joint Preservation Innovations, LLC. FDA's decision date was Nov 21, 2025, under product code HRX (Arthroscope).

Who makes the Articulator Arthroscopic Bur?

Joint Preservation Innovations, LLC, based in Naperville, IL, is the applicant of record for K252666.

How long did the K252666 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Nov 21, 2025, 88 days later.

← All decisions in November 2025