510(k) K143085

Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach by Stryker Orthopaedics — Product Code LPH

K143085 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach". The FDA issued a decision of Substantially Equivalent on February 9, 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. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.