Cleared Traditional

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

K231112 · Materialise NV · Orthopedic

Sep 2023

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K231112 is an FDA 510(k) clearance for the Materialise Shoulder System?, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on September 12, 2023, 146 days after receiving the submission on April 19, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K231112 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 2023
Decision Date	September 12, 2023
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	QHE — Shoulder Arthroplasty Implantation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	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, Attaching, Positioning Or Orienting Implant Components.