Cleared Traditional

Materialise PKA Guide System

K202207 · Materialise NV · Orthopedic

Oct 2020

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K202207 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 October 2, 2020, 57 days after receiving the submission on August 6, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K202207 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2020
Decision Date	October 02, 2020
Days to Decision	57 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