510(k) K161569

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code LPH

K161569 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws". The FDA issued a decision of Substantially Equivalent on October 14, 2016. 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. A.K.A. Stryker Orthopaedics has at least 8 other 510(k) clearances on record.