Cleared Traditional

Materialise PKA Guide System

K173970 · Materialise NV · Orthopedic

Jul 2018

Decision

189d

Days

Class 2

Risk

About This 510(k) Submission

K173970 is an FDA 510(k) clearance for the Materialise PKA Guide System, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on July 6, 2018, 189 days after receiving the submission on December 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K173970 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2017
Decision Date	July 06, 2018
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520