AI devices with FDA product code KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product code KWS (“Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Orthopedic panel (1). The most recent decision was MyShoulder Planner (5.3SSWPL) on January 30, 2025.