510(k) K200718

Arthrosurface WristMotion Total Wrist Arthroplasty System by Arthrosurface, Inc. — Product Code JWJ

K200718 is an FDA 510(k) premarket notification submitted by Arthrosurface, Inc. for the device "Arthrosurface WristMotion Total Wrist Arthroplasty System". The FDA issued a decision of Substantially Equivalent on October 15, 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. Arthrosurface, Inc. has at least 10 other 510(k) clearances on record.