510(k) K181569

BKS Revision Sleeves System by Ortho Development Corporation — Product Code JWH

K181569 is an FDA 510(k) premarket notification submitted by Ortho Development Corporation for the device "BKS Revision Sleeves System". The FDA issued a decision of Substantially Equivalent on October 12, 2018. 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. Ortho Development Corporation has at least 10 other 510(k) clearances on record.