Cleared Traditional

K193560 - Materialise Shoulder Guide and Models

K193560 is the FDA 510(k) clearance for Materialise Shoulder Guide and Models by Materialise NV. It is a Class 2 Orthopedic device (product code QHE) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K193560 · Materialise NV · Orthopedic device
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Mar 2020
Decision
88d
Days
Class 2
Risk

K193560 is an FDA 510(k) clearance for the Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner.... 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 20, 2020 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K193560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2019
Decision Date March 20, 2020
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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.