510(k) K023416

MODIFICATION TO VKS KNEE SYSTEM by Plus Orthopedics — Product Code JWH

K023416 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "MODIFICATION TO VKS KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 2002. 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. Plus Orthopedics has at least 10 other 510(k) clearances on record.