510(k) K101072

TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE by Howmedica Osteonics Corp. — Product Code LPH

K101072 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. for the device "TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE". The FDA issued a decision of Substantially Equivalent on April 11, 2011. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Howmedica Osteonics Corp. has at least 10 other 510(k) clearances on record.