510(k) K243381

Total Wrist Arthroplasty System (TWA) by Skeletal Dynamics, Inc. — Product Code JWJ

K243381 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, Inc. for the device "Total Wrist Arthroplasty System (TWA)". The FDA issued a decision of Substantially Equivalent on November 1, 2024. 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. Skeletal Dynamics, Inc. has at least 10 other 510(k) clearances on record.