Cleared Traditional

K231112 - Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231112 · Materialise NV · Orthopedic device
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Sep 2023
Decision
146d
Days
Class 2
Risk

K231112 is an FDA 510(k) clearance for the Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCas.... 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 September 12, 2023 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Materialise NV devices

Submission Details

510(k) Number K231112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (QHE) and FDA review panel - the closest regulatory comparables to K231112.
Signature™ ONE System
K260104 · Orthosoft Inc. (d/b/a) Zimmer CAS · Feb 2026
Precision AI Surgical Planning System (PAI-SPS)
K251558 · Precision AI Pty, Ltd. · Jan 2026
Archer PSI System
K243509 · 3D-Side · May 2025
CORE Shoulder System
K241470 · LinkBio Corp. · Feb 2025
Precision AI Surgical Planning System (PAI-SPS)
K243955 · Precision AI Pty, Ltd. · Jan 2025
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
K242813 · Materialise NV · Oct 2024