510(k) K191525

KinematX Total Wrist Arthroplasty System by Extremity Medical, LLC — Product Code JWJ

K191525 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "KinematX Total Wrist Arthroplasty System". The FDA issued a decision of Substantially Equivalent on March 4, 2020. The device falls under product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.