510(k) K122015

DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE by Howmedica Osteonics Corp. — Product Code KRO

K122015 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE". The FDA issued a decision of Substantially Equivalent on February 22, 2013. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.