510(k) K261734

Klassic Infection Spacer System by Total Joint Orthopedics, Inc. — Product Code JWH

K261734 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic Infection Spacer System". The FDA issued a decision of Substantially Equivalent on July 23, 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. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.