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

K231112 is the FDA 510(k) clearance record for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, a class II device, cleared for Materialise NV on 2023-09-12 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 K231112.