Cleared Traditional

Materialise TKA Guide System

K221337 · Materialise NV · Orthopedic

Jul 2022

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K221337 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 July 5, 2022, 57 days after receiving the submission on May 9, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K221337 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 2022
Decision Date	July 05, 2022
Days to Decision	57 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