Cleared Traditional

K153602 - Materialise Glenoid Positioning System

K153602 is an FDA 510(k) clearance for Materialise Glenoid Positioning System, manufactured by Materialise NV. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K153602 · Materialise NV · Orthopedic device
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Apr 2016
Decision
131d
Days
Class 2
Risk

K153602 is an FDA 510(k) clearance for the Materialise Glenoid Positioning System. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on April 26, 2016 after a review of 131 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

FDA 510(k) Submission Details - K153602

510(k) Number K153602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2015
Decision Date April 26, 2016
Days to Decision 131 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
9d slower than avg
Panel avg: 122d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K153602.
Arthrex VaultLock Glenoid
K161108 · Arthrex, Inc. · Aug 2016
BLUEPRINT Patient Specific Instrumentation
K160555 · Tornier S.A.S. · Jun 2016
Aequalis PerFORM+ Shoulder System
K160975 · Tornier, Inc. · Jun 2016
SMR 3-Pegs Glenoids
K153722 · Lima Corporate S.P.A. · Apr 2016
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
K160085 · Zimmer GmbH · Mar 2016
SmartBase for Arthrex Glenoid IRIS
K153215 · Custom Orthopaedic Solutions, Inc. · Feb 2016