510(k) K233574

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

K233574 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics for the device "Total Wrist Arthroplasty System (TWA)". The FDA issued a decision of Substantially Equivalent on July 3, 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 has at least 10 other 510(k) clearances on record.