510(k) K111785

FREEDOM(R) STEMMED TIBIAL COMPONENTS by Maxx Orthopedics, Inc. — Product Code JWH

K111785 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "FREEDOM(R) STEMMED TIBIAL COMPONENTS". The FDA issued a decision of Substantially Equivalent on June 29, 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. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.