510(k) K253793

Materialise TKA Guide System by Materialise NV — Product Code JWH

K253793 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Materialise TKA Guide System". The FDA issued a decision of Substantially Equivalent on January 6, 2026. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Materialise NV has at least 10 other 510(k) clearances on record.