Cleared Special

K230315 - Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner

K230315 is an FDA 510(k) clearance for Materialise Shoulder System Materialise..., manufactured by Materialise NV. The device is a Class 2 Orthopedic device with product code QHE cleared through the Special 510(k) pathway after a 28-day FDA review.

K230315 · Materialise NV · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
28d
Days
Class 2
Risk

K230315 is an FDA 510(k) clearance for the Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase .... Classified as Shoulder Arthroplasty Implantation System (product code QHE), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on March 6, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K230315

510(k) Number K230315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2023
Decision Date March 06, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

QHE Device Classification - Class 2, Special Controls

Product Code QHE Shoulder Arthroplasty Implantation System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - QHE Shoulder Arthroplasty Implantation System

All 25
Devices cleared under the same product code (QHE) and FDA review panel - the closest regulatory comparables to K230315.
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
K231112 · Materialise NV · Sep 2023
Arthrex Virtual Implant Positioning (VIP) System
K230904 · Arthrex, Inc. · Jun 2023
Arthrex Virtual Implant Positioning (VIP) System
K222007 · Arthrex, Inc. · Mar 2023
Smart SPACE Shoulder Planner and 3D Positioners
K222405 · Lima Corporate S.P.A. · Dec 2022
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
K220452 · Materialise NV · Aug 2022
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
K212569 · Materialise NV · Jan 2022
K230315 · Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
Download PDF FDA Summary Materialise NV