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Legal, Clinical & Regulatory

Engage Surgical Gains FDA Clearance for Cementless Partial Knee

This is reported to be the only cementless partial knee system available in the U.S. It is cleared for both cementless or cemented fixation.   

IlluminOss Gains FDA Clearance for Treatment of Pelvic, Clavicle and Small-Bone Fractures

The new indication expansion significantly broadens opportunities to address the geriatric fragility fracture market.   

FDA Repeats Call for Advanced Manufacturing Efforts

FDA's CDRH Director Dr. Jeffrey E. Shuren emphasized the need for a greater focus on Advanced Manufacturing during the MDIC 2020 Annual Public Forum. FDA leadership noted COVID-19 has furthered its Advanced Manufacturing efforts, which will be tied to the Case for Quality Initiative.