Cleared Traditional

K220452 - Materialise Shoulder SystemTM 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.

K220452 · Materialise NV · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
181d
Days
Class 2
Risk

K220452 is an FDA 510(k) clearance for the Materialise Shoulder SystemTM 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 August 17, 2022 after a review of 181 days - an extended review cycle.

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 K220452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2022
Decision Date August 17, 2022
Days to Decision 181 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
59d slower than avg
Panel avg: 122d · This submission: 181d
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 K220452.
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