Cleared Traditional

Materialise TKA Guide System

K173445 · Materialise NV · Orthopedic

Feb 2018

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K173445 is an FDA 510(k) clearance for the Materialise TKA Guide System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on February 2, 2018, 88 days after receiving the submission on November 6, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K173445 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2017
Decision Date	February 02, 2018
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560