510(k) K142606

Trident® Tritanium® PST® Acetabular Shells by Mako Surgical Corp. — Product Code LPH

K142606 is an FDA 510(k) premarket notification submitted by Mako Surgical Corp. for the device "Trident® Tritanium® PST® Acetabular Shells". The FDA issued a decision of Substantially Equivalent on January 26, 2015. 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. Mako Surgical Corp. has at least 10 other 510(k) clearances on record.