510(k) K182468

Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — Product Code LPH

K182468 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics for the device "Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System". The FDA issued a decision of Substantially Equivalent on March 19, 2019. 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.