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Legal, Clinical & Regulatory

FDA-Cleared Navigation, Planning and Robotic Systems

Enabling technology will be a large focus in 2020. In preparation for announcements to come, we took stock of FDA 510(k) cleared products from 2018 to 2019.

Arthroscopy Pumps Targeted in New FDA Guidance

FDA released draft guidance for 510(k) submissions of arthroscopy pump tubing sets intended for multiple use after receiving reports of backflow of patient fluids.

In2Bones Gains FDA Clearance for Quantum Total Ankle

The clearance marks the company’s entrance into the total ankle replacement market and complements its products for upper and lower extremities.