Cleared Traditional

Materialise Glenoid Positioning System

K190286 · Materialise NV · Orthopedic

Jul 2019

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K190286 is an FDA 510(k) clearance for the Materialise Glenoid Positioning System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWS), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on July 8, 2019, 147 days after receiving the submission on February 11, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K190286 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2019
Decision Date	July 08, 2019
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

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