510(k) K011810

ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING by Depuy, Inc. — Product Code KRO

K011810 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING". The FDA issued a decision of Substantially Equivalent on September 7, 2001. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Depuy, Inc. has at least 10 other 510(k) clearances on record.