510(k) K112556

ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS by Howmedica Osteonics Corp. — Product Code MEH

K112556 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS". The FDA issued a decision of Substantially Equivalent on September 28, 2011. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.