Cleared Special

Materialise TKA Guide System

K253793 · Materialise NV · Orthopedic

Jan 2026

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K253793 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 January 6, 2026, 39 days after receiving the submission on November 28, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K253793 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2025
Decision Date	January 06, 2026
Days to Decision	39 days
Submission Type	Special
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