Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner

K193560 is the FDA 510(k) clearance record for Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner, a class II device, cleared for Materialise NV on 2020-03-20 under FDA product code QHE (Shoulder Arthroplasty Implantation System). FDA's definition for product code QHE reads: "Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing...". FDA records list 61 510(k) clearances for Materialise NV, from 1997-04-21 to 2026-06-09. As of 2026-09-10, FDA records show no recalls naming K193560.