Cleared Traditional

Materialise TKA Guide System

K251554 · Materialise NV · Orthopedic

Jul 2025

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K251554 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 14, 2025, 54 days after receiving the submission on May 21, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K251554 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 2025
Decision Date	July 14, 2025
Days to Decision	54 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