510(k) K242377

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component by Osteoremedies, LLC — Product Code JWH

K242377 is an FDA 510(k) premarket notification submitted by Osteoremedies, LLC for the device "REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component". The FDA issued a decision of Substantially Equivalent on October 2, 2024. 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. Osteoremedies, LLC has at least 10 other 510(k) clearances on record.