510(k) K202207

Materialise PKA Guide System by Materialise NV — Product Code HSX

K202207 is an FDA 510(k) premarket notification submitted by Materialise NV for the device "Materialise PKA Guide System". The FDA issued a decision of Substantially Equivalent on October 2, 2020. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Materialise NV has at least 10 other 510(k) clearances on record.