Cleared Traditional

K153602 - Materialise Glenoid Positioning System

K153602 is the FDA 510(k) clearance for Materialise Glenoid Positioning System by Materialise NV. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K153602.
AltiVate Anatomic Shoulder System
K162024 · Encore Medical, L.P. · Nov 2016
Arthrex VaultLock Glenoid
K161108 · Arthrex, Inc. · Aug 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
Arthrex Univers Apex, Size 5 Stem
K153115 · Arthrex, Inc. · Nov 2015