510(k) K163497

EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt by Encore Medical L.P. — Product Code KWZ

K163497 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt". The FDA issued a decision of Substantially Equivalent on March 2, 2017. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Encore Medical L.P. has at least 10 other 510(k) clearances on record.