510(k) K113122

PIPELINE CR PRIMARY KNEE SYSTEM by Pipeline Orthopedics — Product Code JWH

K113122 is an FDA 510(k) premarket notification submitted by Pipeline Orthopedics for the device "PIPELINE CR PRIMARY KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 2012. 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. Pipeline Orthopedics has at least 8 other 510(k) clearances on record.