510(k) K992346

KINEMATIC II ROTATING HINGE KNEE by Howmedica Osteonics Corp. — Product Code LGE

K992346 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "KINEMATIC II ROTATING HINGE KNEE". The FDA issued a decision of Substantially Equivalent on August 12, 1999. The device falls under product code LGE (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing), a Class II device regulated under 21 CFR 888.3530. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.